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Performing a Low-dose, Whole-body Angiography as the First Element of an Imaging Assessment Following Stroke / TIA (VASCU)

Primary Purpose

Stroke, Ischemic Attack, Transient

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Routine Imaging Assessment

LDWBA first (CT scan)

About this trial

This is an interventional screening trial for Stroke

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patient was informed about the implementation of the study, its objectives, constraints and patient rights
The patient has given free and informed consent and signed the consent
Patient affiliated with or beneficiary of a health insurance plan
Patient available for 36 months of follow-up
The patient has had a stroke (within the past 10 days, diagnosis confirmed by MRI with a diffusion sequence) or transient ischemic attack (within the past 10 days, ABCD2 score greater than 3) without haemorrhage

Exclusion Criteria:

The patient is currently participating in or has participated in another biomedical research study within the past three months or is currently in an exclusion period determined by a previous study.
Patient under guardianship or judicial protection
Refusal to sign the consent
Inability to correctly inform the patient or his/her trusted person about the study
The patient is pregnant, parturient, or breastfeeding
The patient has a contraindication for a treatment used in this study
Known allergy to contrast medium or severe allergy to iodine
Known active malignancy or history of cancer treatment
The patient has already undergone a full body scanner in the previous three months
Renal failure with creatinine clearance below 60 ml / min
Monoclonal immunoglobulin
History of severe symptomatic cardiovascular event (myocardial infarction, aortic dissection, mesenteric ischemia, renal ischemia)
Emergency situations that hamper the planned course of the study

Sites / Locations

CHRU de Montpellier - Hôpital Gui de ChauliacRecruiting
CHRU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Routine Imaging

LDWBA first

Arm Description

Patients randomized to this arm will have routine post-stroke/TIA imaging assessments. Intervention: Routine Imaging Assessment

Outcomes

Primary Outcome Measures

Presence/absence of at least one element requiring specific treatment

This is a binary variable: the units are "presence/absence". Presence/absence of at least one element (found during the patient's pathway in the imaging service) requiring specific treatment from among the following: Anomaly indicating a high risk for cardio-vascular embolism Anomaly indicating a high risk for vascular thrombosis Any other lesions requiring specific treatment

Secondary Outcome Measures

Diagnostic delay (h)

The time lapsed between inclusion in the study and the first etiological determination of a diagnosis. Thus units (h) is consistent with the time frame.

Length of hospital stay (h)

The units are given in hours even for long stays.

Patient pathway: the number of imaging exams required

Patient pathway: the types of imaging exams required

Total irradiation (mSv) during patient pathway

For contrast injections during the patient pathway: total grams of iodine injected

Number of atherosclerotic sites detected / number of imaging examinations performed

The presence / absence of tight stenosis on the supra aortic arteries

The presence / absence of an occlusion on the supra aortic arteries

The presence / absence of a dissection on the supra aortic arteries

The number of atherosclerotic lesions in the aortic arch

For each atherosclerotic lesion in the aortic arch: plaque thickness (mm)

For each atherosclerotic lesion in the aortic arch: presence/absence of crevices

For each atherosclerotic lesion in the aortic arch: presence/absence of plaque thromboses

Detection of patent foramen ovale (yes/no)

Presence / absence of a thrombus or a circulatory stasis in the left atrium

Extent of atherosclerosis: affects the coronary arteries? yes/no

Extent of atherosclerosis: affects the aortic valve? yes/no

Extent of atherosclerosis: affects the aortic arch? yes/no

Extent of atherosclerosis: affects the abdominal aorta? yes/no

Extent of atherosclerosis: affects the renal arteries? yes/no

Extent of atherosclerosis: affects digestive arteries? yes/no

Extent of atherosclerosis: affects iliac or common femoral arteries? yes/no

Extent of atherosclerosis: affects supra aortic trunks? yes/no

For each detected incidentaloma: volume (mm^3)

The thickness of the left atrial wall

Presence / absence of paroxysmal atrial fibrillation

Presence / absence of a cardiovascular event de novo.

Presence / absence of a cardiovascular event de novo. The following events will be searched for: New stroke or TIA Major Cardiovascular Events (acute symptomatic vascular disease)

Survival (yes/no)

EQ-5D-5L questionnaire

Full Information

NCT ID

NCT02662751

First Posted

November 17, 2015

Last Updated

August 6, 2021

Sponsor

Centre Hospitalier Universitaire de Nīmes

1. Study Identification

Unique Protocol Identification Number

NCT02662751

Brief Title

Performing a Low-dose, Whole-body Angiography as the First Element of an Imaging Assessment Following Stroke / TIA

Acronym

VASCU

Official Title

The Impact of Performing a Low-dose, Whole-body Angiography as the First Element of an Imaging Assessment Following Stroke or Transient Ischemic Attack in Comparison With Usual Care: a Randomized, Controlled, Open Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 21, 2019 (Actual)

Primary Completion Date

September 2021 (Anticipated)

Study Completion Date

October 2021 (Anticipated)

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The main objective of this study is to compare two post-stroke/TIA (transient ischemic attack) imaging strategies in terms of the number of clinically important (i.e. requiring specific treatment according to current recommendations) lesions detected. The first strategy is the current/usual strategy in each participating centre and the second strategy consists in starting the post-stroke/TIA imaging assessment by a whole-body, low-dose angiography and subsequently resorting to elements of the usual strategy if required.

Detailed Description

The secondary objectives are: A. To compare the patient pathways between the two arms in terms of time to diagnosis, and duration of hospitalization. B. To compare the consumption of imaging exams (number and type) and total body irradiation between the two arms. C. To compare the diagnostic efficiency between the two arms in terms of detection of predefined lesions, and performance ratios. D. To study the thickness of the left atrial wall as a risk factor for permanent atrial fibrillation. E. To compare the distribution of suspected neoplasms between the two groups, as well as the number of detected incidentalomas. F. To compare the survival and the incidence of new cardiovascular events between the two arms at 12 months and 36 months. G. To compare the quality of life between the two arms at 12 months and 36 months.

6. Conditions and Keywords

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

Stroke, Ischemic Attack, Transient

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Routine Imaging

Arm Type

Active Comparator

Arm Description

Patients randomized to this arm will have routine post-stroke/TIA imaging assessments. Intervention: Routine Imaging Assessment

Arm Title

LDWBA first

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Routine Imaging Assessment

Intervention Description

Patients will have the usual post-stroke/TIA imaging assessment according to routine procedures in each participating center. The latter most often begin with an angiography of the supra-aortic trunks but may also include a range of other imaging exams depending on the patient's condition. "Routine Imaging Assessment" refers to an imaging strategy and not a specific device. The devices used depend on what is available in participating centres and the routine choices made by those centers.

Intervention Type

Device

Intervention Name(s)

LDWBA first (CT scan)

Intervention Description

Patients randomized to this arm will start their post-stroke/TIA imaging assessment by a low-dose, whole-body angiography (LDWBA). The latter can be followed by routine imaging assessments if required. LDWBA: This is a low dose scanner protocol comprising a CT acquisition and an iodine contrast medium injection. The acquisition includes a propeller during the arterial phase of the contrast agent injection in the cervical and thoracic levels with cardiac gaiting (ECG gating to reduce cardiac motion artifacts), continuing with pelvic abdominal arterial acquisition. The second propeller is made on the abdomen and pelvis at the portal time of injection. The reconstruction will be carried out in pulmonary, mediastinal and bone windows. The dose will be calculated for each patient.

Primary Outcome Measure Information:

Title

Presence/absence of at least one element requiring specific treatment

Description

Time Frame

Day 30

Secondary Outcome Measure Information:

Title

Diagnostic delay (h)

Description

The time lapsed between inclusion in the study and the first etiological determination of a diagnosis. Thus units (h) is consistent with the time frame.

Time Frame

between day 1 and hospital discharge (expected maximum of two weeks)

Title

Length of hospital stay (h)

Description

The units are given in hours even for long stays.

Time Frame

hospital discharge (expected maximum of two weeks)

Title

Patient pathway: the number of imaging exams required

Time Frame

Month 1

Title

Patient pathway: the types of imaging exams required

Time Frame

Month 1

Title

Total irradiation (mSv) during patient pathway

Time Frame

Month 1

Title

For contrast injections during the patient pathway: total grams of iodine injected

Time Frame

Month 1

Title

Number of atherosclerotic sites detected / number of imaging examinations performed

Time Frame

Month 1

Title

The presence / absence of tight stenosis on the supra aortic arteries

Time Frame

Month 1

Title

The presence / absence of an occlusion on the supra aortic arteries

Time Frame

Month 1

Title

The presence / absence of a dissection on the supra aortic arteries

Time Frame

Month 1

Title

The number of atherosclerotic lesions in the aortic arch

Time Frame

Month 1

Title

For each atherosclerotic lesion in the aortic arch: plaque thickness (mm)

Time Frame

Month 1

Title

For each atherosclerotic lesion in the aortic arch: presence/absence of crevices

Time Frame

Month 1

Title

For each atherosclerotic lesion in the aortic arch: presence/absence of plaque thromboses

Time Frame

Month 1

Title

Detection of patent foramen ovale (yes/no)

Time Frame

Month 1

Title

Presence / absence of a thrombus or a circulatory stasis in the left atrium

Time Frame

Month 1

Title

Extent of atherosclerosis: affects the coronary arteries? yes/no

Time Frame

Month 1

Title

Extent of atherosclerosis: affects the aortic valve? yes/no

Time Frame

Month 1

Title

Extent of atherosclerosis: affects the aortic arch? yes/no

Time Frame

Month 1

Title

Extent of atherosclerosis: affects the abdominal aorta? yes/no

Time Frame

Month 1

Title

Extent of atherosclerosis: affects the renal arteries? yes/no

Time Frame

Month 1

Title

Extent of atherosclerosis: affects digestive arteries? yes/no

Time Frame

Month 1

Title

Extent of atherosclerosis: affects iliac or common femoral arteries? yes/no

Time Frame

Month 1

Title

Extent of atherosclerosis: affects supra aortic trunks? yes/no

Time Frame

Month 1

Title

For each detected incidentaloma: volume (mm^3)

Time Frame

Month 1

Title

The thickness of the left atrial wall

Time Frame

Month 1

Title

Presence / absence of paroxysmal atrial fibrillation

Time Frame

36 months

Title

Presence / absence of a cardiovascular event de novo.

Description

Presence / absence of a cardiovascular event de novo. The following events will be searched for: New stroke or TIA Major Cardiovascular Events (acute symptomatic vascular disease)

Time Frame

36 months

Title

Survival (yes/no)

Time Frame

12 months

Title

Survival (yes/no)

Time Frame

36 months

Title

EQ-5D-5L questionnaire

Time Frame

12 months

Title

EQ-5D-5L questionnaire

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient was informed about the implementation of the study, its objectives, constraints and patient rights The patient has given free and informed consent and signed the consent Patient affiliated with or beneficiary of a health insurance plan Patient available for 36 months of follow-up The patient has had a stroke (within the past 10 days, diagnosis confirmed by MRI with a diffusion sequence) or transient ischemic attack (within the past 10 days, ABCD2 score greater than 3) without haemorrhage Exclusion Criteria: The patient is currently participating in or has participated in another biomedical research study within the past three months or is currently in an exclusion period determined by a previous study. Patient under guardianship or judicial protection Refusal to sign the consent Inability to correctly inform the patient or his/her trusted person about the study The patient is pregnant, parturient, or breastfeeding The patient has a contraindication for a treatment used in this study Known allergy to contrast medium or severe allergy to iodine Known active malignancy or history of cancer treatment The patient has already undergone a full body scanner in the previous three months Renal failure with creatinine clearance below 60 ml / min Monoclonal immunoglobulin History of severe symptomatic cardiovascular event (myocardial infarction, aortic dissection, mesenteric ischemia, renal ischemia) Emergency situations that hamper the planned course of the study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Francesco Macri, MD

Phone

+33.(0)6.19.42.18.52

francesco.macri@chu-nimes.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Carey Suehs, PhD

Phone

+33.(0)4.66.68.67.88

carey.suehs@chu-nimes.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francesco Macri, MD

Organizational Affiliation

Centre Hospitalier Universitaire de Nîmes

Official's Role

Study Director

Facility Information:

Facility Name

CHRU de Montpellier - Hôpital Gui de Chauliac

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alain Bonafe, MD, PhD

First Name & Middle Initial & Last Name & Degree

Vincent Costalat, MD

First Name & Middle Initial & Last Name & Degree

Nicolas Menjot de Champfleur, MD

Facility Name

CHRU de Nîmes - Hôpital Universitaire Carémeau

City

Nîmes Cedex 09

ZIP/Postal Code

30029

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francesco Macri, MD

First Name & Middle Initial & Last Name & Degree

Jean Paul Beregi, MD, PhD

First Name & Middle Initial & Last Name & Degree

Cornelia Freitag, MD

First Name & Middle Initial & Last Name & Degree

Liliane Metge, MD

First Name & Middle Initial & Last Name & Degree

Xavier Stefanovic, MD

12. IPD Sharing Statement

Learn more about this trial

Performing a Low-dose, Whole-body Angiography as the First Element of an Imaging Assessment Following Stroke / TIA

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