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Individualized Physical Activity and Carotid Plaque Instability (PACAPh)

Primary Purpose

Carotid Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
individualized home-based physical activity
MRI
blood sampling
Questionnaires
6-minute walk test
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Carotid Atherosclerosis focused on measuring Intraplaque haemorrhage, MRI, home-based Physical activity, carotic plaque vulnerability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with an carotid atheromatous plaque with ≥ 50% North American Symptomatic Carotid Endarterectomy Trial (NASCET) stenosis
  • Patient from vascular surgery department of the Louis Pradel Hospital of the Hospices Civils de Lyon, but not operated
  • Males and females aged over 18 years old
  • No contra-indication to physical activity with index performance (PS) < 2
  • Available and voluntary to invest in the study throughout its duration (6 months)
  • Able to understand, read and write French;
  • a social security system or similar;
  • Having dated and signed informed consent.

Exclusion Criteria:

  • Transient ischemic attack (TIA) or ipsilateral cerebral infarction less than 6 months
  • History of ipsilateral carotid surgery or cervical irradiation;
  • Cancer, heart failure, seropositivity;
  • Coronary risk;
  • Renal failure (Cockcroft clearance of creatinine < 30 milliliter/minute (mL/min);
  • Contraindication and precautions for use related to Prohance: hypersensitivity to the active substance or to any of the constituents of Prohance, renal insufficiency with clearance <30 ml / min / 1.73 m², probability of convulsions during the higher examination in patients with epilepsy or brain injury, pregnancy, breastfeeding;
  • Contraindication to MRI: ferromagnetic material (including pacemaker, implantable defibrillators, cardiac valve prostheses, cochlear implants, neurostimulators, implanted automated injection equipment, intraocular metallic foreign bodies, neurosurgical and vascular clips);
  • Carotid occlusion;
  • ipsilateral intracranial stenosis;
  • Risk of pregnancy or proven pregnancy on interrogation data. Breastfeeding;
  • Patient under guardianship, under curatorship or safeguard of justice;
  • inability to express consent;
  • uncontrolled cardiological or neurological diseases;
  • Impossibility of being followed for medical, social, geographical or psychological reasons throughout the duration of the study.

Sites / Locations

  • Hôpital Louis Pradel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individualized home-based physical activity

Control group

Arm Description

The subjects of this arm will have a daily goal in number of steps based on the initial 2 first week evaluation of daily number of steps. They will wear connected wrists, and will be contacted twice a month by phone call by the adapted physical activity trainer to revaluate these goals.

The subjects of this arm will not have evaluation of daily steps and recommendations regarding physical activity and sedentary behaviour. They will be asked to live as usual.

Outcomes

Primary Outcome Measures

decreased intensity of IPH levels measured by MRI
Image quality will be assessed from 1 to 5 (grade 1, low Signal-to-Noise Ratio (SNR) limits use, arterial wall and vessel margins are unidentifiable; grade 2, marginal SNR, arterial wall is visible, but the substructure, lumen, and outer boundaries are indistinct; grade 3, marginal SNR, wall structures are identifiable, but lumen and outer boundaries are partially obscured; grade 4, high SNR with minimal artifacts, vessel wall, lumen, and adventitial margins are well defined; and grade 5, high SNR without artifacts, wall architecture depicted in detail, lumen and adventitial boundary are clearly defined) . If the quality of the image is sufficient (≥ 3), IPH levels will be semi-quantified on a scale from 0 to 3 (0: No IPH, 1: light IPH, 2 moderate IPH, strong IPH). Images will be assessed blindly and independently by clinical experts of carotid plaque imaging.
decreased intensity of IPH levels measured by MRI
Image quality will be assessed from 1 to 5 (grade 1, low Signal-to-Noise Ratio (SNR) limits use, arterial wall and vessel margins are unidentifiable; grade 2, marginal SNR, arterial wall is visible, but the substructure, lumen, and outer boundaries are indistinct; grade 3, marginal SNR, wall structures are identifiable, but lumen and outer boundaries are partially obscured; grade 4, high SNR with minimal artifacts, vessel wall, lumen, and adventitial margins are well defined; and grade 5, high SNR without artifacts, wall architecture depicted in detail, lumen and adventitial boundary are clearly defined) . If the quality of the image is sufficient (≥ 3), IPH levels will be semi-quantified on a scale from 0 to 3 (0: No IPH, 1: light IPH, 2 moderate IPH, strong IPH). Images will be assessed blindly and independently by clinical experts of carotid plaque imaging.

Secondary Outcome Measures

Evaluation of intermediate monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)+)
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and intermediate phenotypes (in %) will be measured by flow cytometry
Evaluation of intermediate monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)+)
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and intermediate phenotypes (in %) will be measured by flow cytometry
Evaluation of classical monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)-)
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and classical phenotypes (in %) will be measured by flow cytometry
Evaluation of classical monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)-)
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and classical phenotypes (in %) will be measured by flow cytometry
Evaluation of non-classical monocyte phenotype (cluster of differentiation 14 (CD14)+ /cluster of differentiation 16 (CD16)++)
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and non-classical phenotypes (in %) will be measured by flow cytometry
Evaluation of non-classical monocyte phenotype (cluster of differentiation 14 (CD14)+ /cluster of differentiation 16 (CD16)++)
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and non-classical phenotypes (in %) will be measured by flow cytometry
Assessment of red blood cell aggregation
Red blood cell aggregation (in %)will be measured by ektacytometry
Assessment of red blood cell aggregation
Red blood cell aggregation (in %) will be measured by ektacytometry
in vitro clotting formation time
In vitro clotting formation time (in minutes) will be measured on whole blood by rotational thromboelastometry
in vitro clotting formation time
In vitro clotting formation time (in minutes) will be measured on whole blood by rotational thromboelastometry
Measurement of in vitro clot lysis index
In vitro clot lysis index (in millimeter) will be measured on whole blood by rotational thromboelastometry
Measurement of in vitro clot lysis index
In vitro clot lysis index (in millimeter) will be measured on whole blood by rotational thromboelastometry
Measurement of in vitro clot firmness
In vitro clot firmness (in millimeter) will be measured on whole blood by rotational thromboelastometry
Measurement of in vitro clot firmness
In vitro clot firmness (in millimeter) will be measured on whole blood by rotational thromboelastometry
Assessment of plasma lipid oxidation
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Assessment of plasma lipid oxidation
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Assessment of plasma protein oxidation
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Assessment of plasma protein oxidation
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Assessment of plasma protein nitration
Plasma protein nitration (nitrotyrosine) measured by the enzyme-linked immunosorbent assay (ELISA) in micromole/liter (µmol/L).
Assessment of plasma protein nitration
Plasma protein nitration (nitrotyrosine) measured by the enzyme-linked immunosorbent assay (ELISA) in micromole/liter (µmol/L).
Assessment of plasma inflammatory markers
Plasma inflammatory markers will be measured by multiplex assay in micromole/liter (µmol/L).
Assessment of plasma inflammatory markers
Plasma inflammatory markers will be measured by multiplex assay in micromole/liter (µmol/L).
Assessment of plasma enzymes activity
Plasma antioxidant enzymes activity will be measured by enzymology (in micromole/liter/minute (µmol/L/min))
Assessment of plasma enzymes activity
Plasma antioxidant enzymes activity will be measured by enzymology (in micromole/liter/minute (µmol/L/min))
number of steps per day
the daily number of steps (in number of step per day) will be measured using a connected wrist activity tracker
number of steps per day
the daily number of steps (in number of step per day) will be measured using a connected wrist activity tracker
distance of the 6 minutes walking test
The distance at the 6 minutes walking test (in meters) will be evaluated on the 30meters flat round-trip
distance of the 6 minutes walking test
The distance at the 6 minutes walking test (in meters) will be evaluated on the 30meters flat round-trip
quadriceps maximal isometric strength
The quadriceps maximal isometric strength (in Newton) will be evaluated in sitting position using dynamometer
quadriceps maximal isometric strength
The quadriceps maximal isometric strength (in Newton) will be evaluated in sitting position using dynamometer
Determination of the level of physical activity
the level physical activity will be evaluated by the global physical activity questionnaire (in Metabolic Equivalent of Task/minutes per week (MET/min.week)).
Determination of the level of physical activity
the level physical activity will be evaluated by the global physical activity questionnaire (in Metabolic Equivalent of Task/minutes per week (MET/min.week)).
Determination of the sedentary time
Sedentary time will be evaluated by the sedentary behaviour questionnaire evaluating the total daily sitting and lying down time (in minute/day) during awaking time.
Determination of the sedentary time
Sedentary time will be evaluated by the sedentary behaviour questionnaire evaluating the total daily sitting and lying down time (in minute/day) during awaking time.
descriptive health state score
Health state score will be assessed using descriptive system of the EQ-5D-5L (five-level version of the EuroQol five-dimensional) questionnaire. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The subjects self-rate their level of severity for each dimension using a five-level (EQ-5D-5L) scale (scored from 1 to 5, 1 indicating no problem and 5 indicating extreme problem). The health rate score correspond to the addition of each dimension score and is from 5 to 25. The lower the score, the better the health state.
descriptive health state score
Health state score will be assessed using descriptive system of the EQ-5D-5L (five-level version of the EuroQol five-dimensional) questionnaire. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The subjects self-rate their level of severity for each dimension using a five-level (EQ-5D-5L) scale (scored from 1 to 5, 1 indicating no problem and 5 indicating extreme problem). The health rate score correspond to the addition of each dimension score and is from 5 to 25. The lower the score, the better the health state.
self-evaluated overall health status
Overall health status will be assessed using the evaluation part of the EQ-5D-5L (five-level version of the EuroQol five-dimensional) questionnaire. The subject's self- evaluate their overall health status using the visual analogue scale (EQ-VAS). The raw score is from 0 to 100. The higher the score, the better the perceived overall health status
self-evaluated overall health status
Overall health status will be assessed using the evaluation part of the EQ-5D-5L (five-level version of the EuroQol five-dimensional) questionnaire. The subject's self- evaluate their overall health status using the visual analogue scale (EQ-VAS). The raw score is from 0 to 100. The higher the score, the better the perceived overall health status
body mass index
Body mass index (in kilogram/metre² (kg/m²)) will be calculated with the measurement of body weight (in kilogram) and height (in meter)
body mass index
Body mass index (in kilogram/metre² (kg/m²)) will be calculated with the measurement of body weight (in kilogram) and height (in meter)
number of comorbidities
Number of comorbidities (Diabetes, hypertension, obesity and , poly-atheroma) will be determined
number of comorbidities
Number of comorbidities (Diabetes, hypertension, obesity and , poly-atheroma) will be determined

Full Information

First Posted
August 6, 2019
Last Updated
November 16, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04053166
Brief Title
Individualized Physical Activity and Carotid Plaque Instability
Acronym
PACAPh
Official Title
Effect of an Individualized Home-based Physical Activity Trial on Carotid Plaque Vulnerability for Asymptomatic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
September 12, 2022 (Actual)
Study Completion Date
September 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Intraplaque hemorrhage (IPH) is one of the main features of the carotid plaque instability's and predictor of ischemic stroke. Benefits (on the basis on benefit/risk ratio) of the carotid endarterectomy remain unclear for stroke asymptomatic patients; thus, more and more patients with important stenosis (i.e. over 60%) detected are not operated. However, these patients need adapted therapeutic treatments to limit plaque instability and this should include physical activity (PA). Indeed, PA has been showed to decrease numerous inflammatory markers involved in atherosclerosis. It has also recently been reported on stroke asymptomatic patients that the prevalence of carotid IPH was decreased in those with higher level of PA. Magnetic Resonance Imaging (MRI) of the IPH has been shown to be the better non-invasive imaging technique to assess carotid plaque instability and in particular IPH. Here, the aim of this study is to assess the effect of an individualized home-based 6 months physical activity intervention on carotid IPH and other biomarkers of vulnerability for asymptomatic patients. This study has been designed as a monocentric, longitudinal and interventional study. This study will involve one centre: Hopital Louis Pradel (HCL, Lyon). After inclusion tests, patients will be randomly included in the control group, or in the PA group. Patients of the PA group will have connected bracelets to measure daily count of steps. Twice a month, daily goals will be revaluated to increase or maintain the steps per day. The final goal is to reach 6 000 steps per day or increase by 30% the initial count of steps per day. Same tests will be done after 6 months of intervention for comparison.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Atherosclerosis
Keywords
Intraplaque haemorrhage, MRI, home-based Physical activity, carotic plaque vulnerability

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Two experienced observers will blindly read the MRI scans.
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized home-based physical activity
Arm Type
Experimental
Arm Description
The subjects of this arm will have a daily goal in number of steps based on the initial 2 first week evaluation of daily number of steps. They will wear connected wrists, and will be contacted twice a month by phone call by the adapted physical activity trainer to revaluate these goals.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The subjects of this arm will not have evaluation of daily steps and recommendations regarding physical activity and sedentary behaviour. They will be asked to live as usual.
Intervention Type
Device
Intervention Name(s)
individualized home-based physical activity
Intervention Description
Subjects will have to reach a daily goal in number of steps, based on the initial evaluation, during 6 months . They will wear connected wrists, and will be contacted twice a month by phone call by an adapted physical activity to revaluate these goals.
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
An MRI will be performed for each patient at the end of the study to identify IPH and other features of histological vulnerability (lipid core, fibrous cap integrity and calcifications).
Intervention Type
Biological
Intervention Name(s)
blood sampling
Intervention Description
Blood will be collected, to analyse monocyte phenotype by flow cytometry, blood rheology by ektacytometry, coagulation by rotational thromboelastometry (ROTEM). Plasma will be extracted from blood to assess inflammation, oxidative stress and antioxidant markers.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
sedentary, physical activity, nutrition and quality of life questionnaire will be performed fo each patient.
Intervention Type
Other
Intervention Name(s)
6-minute walk test
Intervention Description
The 6-minute walk test is a simple, individualized test that measures how fast a patient walks on a flat, hard surface for 6 minutes.
Primary Outcome Measure Information:
Title
decreased intensity of IPH levels measured by MRI
Description
Image quality will be assessed from 1 to 5 (grade 1, low Signal-to-Noise Ratio (SNR) limits use, arterial wall and vessel margins are unidentifiable; grade 2, marginal SNR, arterial wall is visible, but the substructure, lumen, and outer boundaries are indistinct; grade 3, marginal SNR, wall structures are identifiable, but lumen and outer boundaries are partially obscured; grade 4, high SNR with minimal artifacts, vessel wall, lumen, and adventitial margins are well defined; and grade 5, high SNR without artifacts, wall architecture depicted in detail, lumen and adventitial boundary are clearly defined) . If the quality of the image is sufficient (≥ 3), IPH levels will be semi-quantified on a scale from 0 to 3 (0: No IPH, 1: light IPH, 2 moderate IPH, strong IPH). Images will be assessed blindly and independently by clinical experts of carotid plaque imaging.
Time Frame
Day 0
Title
decreased intensity of IPH levels measured by MRI
Description
Image quality will be assessed from 1 to 5 (grade 1, low Signal-to-Noise Ratio (SNR) limits use, arterial wall and vessel margins are unidentifiable; grade 2, marginal SNR, arterial wall is visible, but the substructure, lumen, and outer boundaries are indistinct; grade 3, marginal SNR, wall structures are identifiable, but lumen and outer boundaries are partially obscured; grade 4, high SNR with minimal artifacts, vessel wall, lumen, and adventitial margins are well defined; and grade 5, high SNR without artifacts, wall architecture depicted in detail, lumen and adventitial boundary are clearly defined) . If the quality of the image is sufficient (≥ 3), IPH levels will be semi-quantified on a scale from 0 to 3 (0: No IPH, 1: light IPH, 2 moderate IPH, strong IPH). Images will be assessed blindly and independently by clinical experts of carotid plaque imaging.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Evaluation of intermediate monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)+)
Description
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and intermediate phenotypes (in %) will be measured by flow cytometry
Time Frame
Day 0
Title
Evaluation of intermediate monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)+)
Description
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and intermediate phenotypes (in %) will be measured by flow cytometry
Time Frame
Month 6
Title
Evaluation of classical monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)-)
Description
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and classical phenotypes (in %) will be measured by flow cytometry
Time Frame
Day 0
Title
Evaluation of classical monocyte phenotype (cluster of differentiation 14 (CD14)++ /cluster of differentiation 16 (CD16)-)
Description
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and classical phenotypes (in %) will be measured by flow cytometry
Time Frame
Month 6
Title
Evaluation of non-classical monocyte phenotype (cluster of differentiation 14 (CD14)+ /cluster of differentiation 16 (CD16)++)
Description
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and non-classical phenotypes (in %) will be measured by flow cytometry
Time Frame
Day 0
Title
Evaluation of non-classical monocyte phenotype (cluster of differentiation 14 (CD14)+ /cluster of differentiation 16 (CD16)++)
Description
monocytes will be extracted from blood sample, marked with specific antibodies (anti CD14/16) and non-classical phenotypes (in %) will be measured by flow cytometry
Time Frame
Month 6
Title
Assessment of red blood cell aggregation
Description
Red blood cell aggregation (in %)will be measured by ektacytometry
Time Frame
Day 0
Title
Assessment of red blood cell aggregation
Description
Red blood cell aggregation (in %) will be measured by ektacytometry
Time Frame
Month 6
Title
in vitro clotting formation time
Description
In vitro clotting formation time (in minutes) will be measured on whole blood by rotational thromboelastometry
Time Frame
Day 0
Title
in vitro clotting formation time
Description
In vitro clotting formation time (in minutes) will be measured on whole blood by rotational thromboelastometry
Time Frame
Month 6
Title
Measurement of in vitro clot lysis index
Description
In vitro clot lysis index (in millimeter) will be measured on whole blood by rotational thromboelastometry
Time Frame
Day 0
Title
Measurement of in vitro clot lysis index
Description
In vitro clot lysis index (in millimeter) will be measured on whole blood by rotational thromboelastometry
Time Frame
Month 6
Title
Measurement of in vitro clot firmness
Description
In vitro clot firmness (in millimeter) will be measured on whole blood by rotational thromboelastometry
Time Frame
Day 0
Title
Measurement of in vitro clot firmness
Description
In vitro clot firmness (in millimeter) will be measured on whole blood by rotational thromboelastometry
Time Frame
Month 6
Title
Assessment of plasma lipid oxidation
Description
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Time Frame
Day 0
Title
Assessment of plasma lipid oxidation
Description
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Time Frame
Month 6
Title
Assessment of plasma protein oxidation
Description
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Time Frame
Day 0
Title
Assessment of plasma protein oxidation
Description
Plasma protein oxidation (advanced oxidation proteins products) measured by by spectrophotometry (in micromole/liter (µmol/L))
Time Frame
Month 6
Title
Assessment of plasma protein nitration
Description
Plasma protein nitration (nitrotyrosine) measured by the enzyme-linked immunosorbent assay (ELISA) in micromole/liter (µmol/L).
Time Frame
Day 0
Title
Assessment of plasma protein nitration
Description
Plasma protein nitration (nitrotyrosine) measured by the enzyme-linked immunosorbent assay (ELISA) in micromole/liter (µmol/L).
Time Frame
Month 6
Title
Assessment of plasma inflammatory markers
Description
Plasma inflammatory markers will be measured by multiplex assay in micromole/liter (µmol/L).
Time Frame
Day 0
Title
Assessment of plasma inflammatory markers
Description
Plasma inflammatory markers will be measured by multiplex assay in micromole/liter (µmol/L).
Time Frame
Month 6
Title
Assessment of plasma enzymes activity
Description
Plasma antioxidant enzymes activity will be measured by enzymology (in micromole/liter/minute (µmol/L/min))
Time Frame
Day 0
Title
Assessment of plasma enzymes activity
Description
Plasma antioxidant enzymes activity will be measured by enzymology (in micromole/liter/minute (µmol/L/min))
Time Frame
Month 6
Title
number of steps per day
Description
the daily number of steps (in number of step per day) will be measured using a connected wrist activity tracker
Time Frame
during 2 weeks after Day 0
Title
number of steps per day
Description
the daily number of steps (in number of step per day) will be measured using a connected wrist activity tracker
Time Frame
during 2 weeks after Month 6
Title
distance of the 6 minutes walking test
Description
The distance at the 6 minutes walking test (in meters) will be evaluated on the 30meters flat round-trip
Time Frame
Day 0
Title
distance of the 6 minutes walking test
Description
The distance at the 6 minutes walking test (in meters) will be evaluated on the 30meters flat round-trip
Time Frame
Month 6
Title
quadriceps maximal isometric strength
Description
The quadriceps maximal isometric strength (in Newton) will be evaluated in sitting position using dynamometer
Time Frame
Day 0
Title
quadriceps maximal isometric strength
Description
The quadriceps maximal isometric strength (in Newton) will be evaluated in sitting position using dynamometer
Time Frame
Month 6
Title
Determination of the level of physical activity
Description
the level physical activity will be evaluated by the global physical activity questionnaire (in Metabolic Equivalent of Task/minutes per week (MET/min.week)).
Time Frame
Day 0
Title
Determination of the level of physical activity
Description
the level physical activity will be evaluated by the global physical activity questionnaire (in Metabolic Equivalent of Task/minutes per week (MET/min.week)).
Time Frame
Month 6
Title
Determination of the sedentary time
Description
Sedentary time will be evaluated by the sedentary behaviour questionnaire evaluating the total daily sitting and lying down time (in minute/day) during awaking time.
Time Frame
Day 0
Title
Determination of the sedentary time
Description
Sedentary time will be evaluated by the sedentary behaviour questionnaire evaluating the total daily sitting and lying down time (in minute/day) during awaking time.
Time Frame
Month 6
Title
descriptive health state score
Description
Health state score will be assessed using descriptive system of the EQ-5D-5L (five-level version of the EuroQol five-dimensional) questionnaire. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The subjects self-rate their level of severity for each dimension using a five-level (EQ-5D-5L) scale (scored from 1 to 5, 1 indicating no problem and 5 indicating extreme problem). The health rate score correspond to the addition of each dimension score and is from 5 to 25. The lower the score, the better the health state.
Time Frame
Day 0
Title
descriptive health state score
Description
Health state score will be assessed using descriptive system of the EQ-5D-5L (five-level version of the EuroQol five-dimensional) questionnaire. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The subjects self-rate their level of severity for each dimension using a five-level (EQ-5D-5L) scale (scored from 1 to 5, 1 indicating no problem and 5 indicating extreme problem). The health rate score correspond to the addition of each dimension score and is from 5 to 25. The lower the score, the better the health state.
Time Frame
Month 6
Title
self-evaluated overall health status
Description
Overall health status will be assessed using the evaluation part of the EQ-5D-5L (five-level version of the EuroQol five-dimensional) questionnaire. The subject's self- evaluate their overall health status using the visual analogue scale (EQ-VAS). The raw score is from 0 to 100. The higher the score, the better the perceived overall health status
Time Frame
Day 0
Title
self-evaluated overall health status
Description
Overall health status will be assessed using the evaluation part of the EQ-5D-5L (five-level version of the EuroQol five-dimensional) questionnaire. The subject's self- evaluate their overall health status using the visual analogue scale (EQ-VAS). The raw score is from 0 to 100. The higher the score, the better the perceived overall health status
Time Frame
Month 6
Title
body mass index
Description
Body mass index (in kilogram/metre² (kg/m²)) will be calculated with the measurement of body weight (in kilogram) and height (in meter)
Time Frame
Day 0
Title
body mass index
Description
Body mass index (in kilogram/metre² (kg/m²)) will be calculated with the measurement of body weight (in kilogram) and height (in meter)
Time Frame
Month 6
Title
number of comorbidities
Description
Number of comorbidities (Diabetes, hypertension, obesity and , poly-atheroma) will be determined
Time Frame
Day 0
Title
number of comorbidities
Description
Number of comorbidities (Diabetes, hypertension, obesity and , poly-atheroma) will be determined
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with an carotid atheromatous plaque with ≥ 50% North American Symptomatic Carotid Endarterectomy Trial (NASCET) stenosis Patient from vascular surgery department of the Louis Pradel Hospital of the Hospices Civils de Lyon, but not operated Males and females aged over 18 years old No contra-indication to physical activity with index performance (PS) < 2 Available and voluntary to invest in the study throughout its duration (6 months) Able to understand, read and write French; a social security system or similar; Having dated and signed informed consent. Exclusion Criteria: Transient ischemic attack (TIA) or ipsilateral cerebral infarction less than 6 months History of ipsilateral carotid surgery or cervical irradiation; Cancer, heart failure, seropositivity; Coronary risk; Renal failure (Cockcroft clearance of creatinine < 30 milliliter/minute (mL/min); Contraindication and precautions for use related to Prohance: hypersensitivity to the active substance or to any of the constituents of Prohance, renal insufficiency with clearance <30 ml / min / 1.73 m², probability of convulsions during the higher examination in patients with epilepsy or brain injury, pregnancy, breastfeeding; Contraindication to MRI: ferromagnetic material (including pacemaker, implantable defibrillators, cardiac valve prostheses, cochlear implants, neurostimulators, implanted automated injection equipment, intraocular metallic foreign bodies, neurosurgical and vascular clips); Carotid occlusion; ipsilateral intracranial stenosis; Risk of pregnancy or proven pregnancy on interrogation data. Breastfeeding; Patient under guardianship, under curatorship or safeguard of justice; inability to express consent; uncontrolled cardiological or neurological diseases; Impossibility of being followed for medical, social, geographical or psychological reasons throughout the duration of the study.
Facility Information:
Facility Name
Hôpital Louis Pradel
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35164816
Citation
Mura M, Rivoire E, Dehina-Khenniche L, Weiss-Gayet M, Chazaud B, Faes C, Connes P, Long A, Rytz CL, Mury P, Delrieu L, Gouraud E, Bordet M, Della Schiava N, Lermusiaux P, Arsicot M, Millon A, Pialoux V. Effectiveness of an individualized home-based physical activity program in surgery-free non-endarterectomized asymptomatic stroke patients: a study protocol for the PACAPh interventional randomized trial. Trials. 2022 Feb 14;23(1):145. doi: 10.1186/s13063-022-06061-x. Erratum In: Trials. 2022 Mar 22;23(1):230.
Results Reference
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Individualized Physical Activity and Carotid Plaque Instability

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