search
Back to results

Post Infarction Exercise Effects on Myocardial Function Assessed by 2D Strain Ultrasound (TrainStrain)

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac training program
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 4 months of follow-up
  • The patient had a first myocardial infarction episode (within the past 3 months) requiring medical treatment or revascularisation (e.g. balloon angioplasty) or aortocoronary bypass

Exclusion Criteria:

  • The patient is simultaneously participating in (or has participated in the past 3 months) another interventional study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection or under guardianship
  • It is impossible to correctly inform the patient or the patient refuses to sign the consent
  • The patient is pregnant, parturient, or breastfeeding
  • Contra indication for exercise training
  • Valve prosthesis
  • Severe valvular disease
  • Pacemaker
  • Heart transplant
  • Non sinus rhythm

Sites / Locations

  • CHU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise training

No exercise training

Arm Description

Patients in this arm were encouraged to participate in an exercise training program, and they accepted to do so. Intervention: Cardiac training program

Patients in this arm were encouraged to participate in an exercise training program, and they refused to do so.

Outcomes

Primary Outcome Measures

The % global longitudinal strain of the left ventricle
The % global longitudinal strain of the left ventricle
The % global longitudinal strain of the left ventricle

Secondary Outcome Measures

maximal oxygen consumption (VO2max; mL/min/kg)
maximal oxygen consumption (VO2max; mL/min/kg)
maximal oxygen consumption (VO2max; mL/min/kg)
maximum aerobic power (watts)
maximum aerobic power (watts)
maximum aerobic power (watts)
First ventilatory threshold (mL/min/kg)
First ventilatory threshold (mL/min/kg)
First ventilatory threshold (mL/min/kg)
left ventricle longitudinal systolic strain rate
left ventricle longitudinal systolic strain rate
left ventricle longitudinal systolic strain rate
left ventricle longitudinal diastolic strain rate
left ventricle longitudinal diastolic strain rate
left ventricle longitudinal diastolic strain rate
% radial systolic strain
% radial systolic strain
% radial systolic strain
% radial diastolic strain
% radial diastolic strain
% radial diastolic strain
% circumferential systolic strain
% circumferential systolic strain
% circumferential systolic strain
% circumferential diastolic strain
% circumferential diastolic strain
% circumferential diastolic strain
Radial systolic strain rate
Radial systolic strain rate
Radial systolic strain rate
Radial diastolic strain rate
Radial diastolic strain rate
Radial diastolic strain rate
Circumferential systolic strain rate
Circumferential systolic strain rate
Circumferential systolic strain rate
Circumferential diastolic strain rate
Circumferential diastolic strain rate
Circumferential diastolic strain rate
Telediastolic volume (mL)
Telesystolic volume (mL)
Telesystolic volume (mL)
Telediastolic volume (mL)
Telediastolic volume (mL)
Left ventricle mass (g/m^2)
Left ventricle mass (g/m^2)
Left ventricle mass (g/m^2)
Ejection fraction of the left ventricle
Ejection fraction of the left ventricle
Ejection fraction of the left ventricle
S' wave velocity (cm/s)
S' wave velocity (cm/s)
S' wave velocity (cm/s)
E' wave velocity (cm/s)
E' wave velocity (cm/s)
E' wave velocity (cm/s)
A' wave velocity (cm/s)
A' wave velocity (cm/s)
A' wave velocity (cm/s)
The E/A ratio
The E/A ratio
The E/A ratio

Full Information

First Posted
October 12, 2016
Last Updated
October 23, 2019
Sponsor
Centre Hospitalier Universitaire de Nīmes
search

1. Study Identification

Unique Protocol Identification Number
NCT02932696
Brief Title
Post Infarction Exercise Effects on Myocardial Function Assessed by 2D Strain Ultrasound
Acronym
TrainStrain
Official Title
Post Infarction Exercise Training Effects on Systolic and Diastolic Myocardial Function Assessed by 2D Strain Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
July 11, 2019 (Actual)
Study Completion Date
July 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

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

5. Study Description

Brief Summary
The main goal of our project is to study and describe the effect of exercise training on systolic and diastolic myocardial function assessed by 2D ultrasound strain after myocardial infarction. Our working hypothesis is that the intrinsic myocardial contractility and relaxation assessed by global longitudinal strain in phase II (or 2D strain) during post-infarction exercise training will be improved compared to baseline values as well as compared to values in a no-training group. Should this hypothesis prove true, it would help explain the improvements in functional capacity observed during the post-infarction period and after exercise training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training
Arm Type
Experimental
Arm Description
Patients in this arm were encouraged to participate in an exercise training program, and they accepted to do so. Intervention: Cardiac training program
Arm Title
No exercise training
Arm Type
No Intervention
Arm Description
Patients in this arm were encouraged to participate in an exercise training program, and they refused to do so.
Intervention Type
Other
Intervention Name(s)
Cardiac training program
Intervention Description
This program takes place at the Cardiovascular Rehabilitation Department at the Nîmes University Hospital and includes a combination of various physical activities: treadmill, exercise bike, rower, aerobics, gymnastics, serious games, swimming. The program begins approximately within 3 months after myocardial infarction and consists of 20 consecutive days of training. The main physical activity is aerobic interval training (AIT). 30-minute AIT sessions will occur 5x per week for 4 weeks. 1 AIT session includes a warm up for 8 minutes to reach a heart rate during exercise corresponding to 20 to 30% of maximum aerobic power determined during the initial effort test. Then interval training occurs with 4x2 min of high intensity effort (heart rate during exercise corresponding to 80% of maximum aerobic power) alternating with 2 min of active recovery at 20-30% of maximum aerobic power. Then recovery for 8 minutes.
Primary Outcome Measure Information:
Title
The % global longitudinal strain of the left ventricle
Time Frame
within 3 months post infarction = T0 (baseline)
Title
The % global longitudinal strain of the left ventricle
Time Frame
5 weeks
Title
The % global longitudinal strain of the left ventricle
Time Frame
3 months
Secondary Outcome Measure Information:
Title
maximal oxygen consumption (VO2max; mL/min/kg)
Time Frame
within 3 months post infarction = T0 (baseline)
Title
maximal oxygen consumption (VO2max; mL/min/kg)
Time Frame
T0 + 5 weeks
Title
maximal oxygen consumption (VO2max; mL/min/kg)
Time Frame
T0 + 3 months
Title
maximum aerobic power (watts)
Time Frame
within 3 months post infarction = T0 (baseline)
Title
maximum aerobic power (watts)
Time Frame
T0 + 5 weeks
Title
maximum aerobic power (watts)
Time Frame
T0 + 3 months
Title
First ventilatory threshold (mL/min/kg)
Time Frame
within 3 months post infarction = T0 (baseline)
Title
First ventilatory threshold (mL/min/kg)
Time Frame
T0 + 5 weeks
Title
First ventilatory threshold (mL/min/kg)
Time Frame
T0 + 3 months
Title
left ventricle longitudinal systolic strain rate
Time Frame
within 3 months post infarction = T0 (baseline)
Title
left ventricle longitudinal systolic strain rate
Time Frame
T0 + 5 weeks
Title
left ventricle longitudinal systolic strain rate
Time Frame
T0 + 3 months
Title
left ventricle longitudinal diastolic strain rate
Time Frame
within 3 months post infarction = T0 (baseline)
Title
left ventricle longitudinal diastolic strain rate
Time Frame
T0 + 5 weeks
Title
left ventricle longitudinal diastolic strain rate
Time Frame
T0 + 3 months
Title
% radial systolic strain
Time Frame
within 3 months post infarction = T0 (baseline)
Title
% radial systolic strain
Time Frame
T0 + 5 weeks
Title
% radial systolic strain
Time Frame
T0 + 3 months
Title
% radial diastolic strain
Time Frame
within 3 months post infarction = T0 (baseline)
Title
% radial diastolic strain
Time Frame
T0 + 5 weeks
Title
% radial diastolic strain
Time Frame
T0 + 3 months
Title
% circumferential systolic strain
Time Frame
within 3 months post infarction = T0 (baseline)
Title
% circumferential systolic strain
Time Frame
T0 + 5 weeks
Title
% circumferential systolic strain
Time Frame
T0 + 3 months
Title
% circumferential diastolic strain
Time Frame
within 3 months post infarction = T0 (baseline)
Title
% circumferential diastolic strain
Time Frame
T0 + 5 weeks
Title
% circumferential diastolic strain
Time Frame
T0 + 3 months
Title
Radial systolic strain rate
Time Frame
within 3 months post infarction = T0 (baseline)
Title
Radial systolic strain rate
Time Frame
T0 + 5 weeks
Title
Radial systolic strain rate
Time Frame
T0 + 3 months
Title
Radial diastolic strain rate
Time Frame
within 3 months post infarction = T0 (baseline)
Title
Radial diastolic strain rate
Time Frame
T0 + 5 weeks
Title
Radial diastolic strain rate
Time Frame
T0 + 3 months
Title
Circumferential systolic strain rate
Time Frame
within 3 months post infarction = T0 (baseline)
Title
Circumferential systolic strain rate
Time Frame
T0 + 5 weeks
Title
Circumferential systolic strain rate
Time Frame
T0 + 3 months
Title
Circumferential diastolic strain rate
Time Frame
within 3 months post infarction = T0 (baseline)
Title
Circumferential diastolic strain rate
Time Frame
T0 + 5 weeks
Title
Circumferential diastolic strain rate
Time Frame
T0 + 3 months
Title
Telediastolic volume (mL)
Time Frame
within 3 months post infarction = T0 (baseline)
Title
Telesystolic volume (mL)
Time Frame
T0 + 5 weeks
Title
Telesystolic volume (mL)
Time Frame
T0 + 3 months
Title
Telediastolic volume (mL)
Time Frame
T0 + 5 weeks
Title
Telediastolic volume (mL)
Time Frame
T0 + 3 months
Title
Left ventricle mass (g/m^2)
Time Frame
within 3 months post infarction = T0 (baseline)
Title
Left ventricle mass (g/m^2)
Time Frame
T0 + 5 weeks
Title
Left ventricle mass (g/m^2)
Time Frame
T0 + 3 months
Title
Ejection fraction of the left ventricle
Time Frame
within 3 months post infarction = T0 (baseline)
Title
Ejection fraction of the left ventricle
Time Frame
T0 + 5 weeks
Title
Ejection fraction of the left ventricle
Time Frame
T0 + 3 months
Title
S' wave velocity (cm/s)
Time Frame
within 3 months post infarction = T0 (baseline)
Title
S' wave velocity (cm/s)
Time Frame
T0 + 5 weeks
Title
S' wave velocity (cm/s)
Time Frame
T0 + 3 months
Title
E' wave velocity (cm/s)
Time Frame
within 3 months post infarction = T0 (baseline)
Title
E' wave velocity (cm/s)
Time Frame
T0 + 5 weeks
Title
E' wave velocity (cm/s)
Time Frame
T0 + 3 months
Title
A' wave velocity (cm/s)
Time Frame
within 3 months post infarction = T0 (baseline)
Title
A' wave velocity (cm/s)
Time Frame
T0 + 5 weeks
Title
A' wave velocity (cm/s)
Time Frame
T0 + 3 months
Title
The E/A ratio
Time Frame
within 3 months post infarction = T0 (baseline)
Title
The E/A ratio
Time Frame
T0 + 5 weeks
Title
The E/A ratio
Time Frame
T0 + 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is available for 4 months of follow-up The patient had a first myocardial infarction episode (within the past 3 months) requiring medical treatment or revascularisation (e.g. balloon angioplasty) or aortocoronary bypass Exclusion Criteria: The patient is simultaneously participating in (or has participated in the past 3 months) another interventional study The patient is in an exclusion period determined by a previous study The patient is under judicial protection or under guardianship It is impossible to correctly inform the patient or the patient refuses to sign the consent The patient is pregnant, parturient, or breastfeeding Contra indication for exercise training Valve prosthesis Severe valvular disease Pacemaker Heart transplant Non sinus rhythm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Dupeyron, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Learn more about this trial

Post Infarction Exercise Effects on Myocardial Function Assessed by 2D Strain Ultrasound

We'll reach out to this number within 24 hrs