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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Ischemic Attack, Transient
• Intervention / Treatment: Other: Routine Imaging Assessment; Device: LDWBA first (CT scan)

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.

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesco Macri, MD; Phone Number: +33.(0)6.19.42.18.52; Email: francesco.macri@chu-nimes.fr
• Study Contact Backup: Name: Carey Suehs, PhD; Phone Number: +33.(0)4.66.68.67.88; Email: carey.suehs@chu-nimes.fr

Study Locations

• France
  • Montpellier Cedex 5, France, 34295
    • Recruiting
    • CHRU de Montpellier - Hôpital Gui de Chauliac
    • Principal Investigator: Alain Bonafe, MD, PhD
    • Sub-Investigator: Vincent Costalat, MD
    • Sub-Investigator: Nicolas Menjot de Champfleur, MD
  • Nîmes Cedex 09, France, 30029
    • Not yet recruiting
    • CHRU de Nîmes - Hôpital Universitaire Carémeau
    • Sub-Investigator: Francesco Macri, MD
    • Principal Investigator: Jean Paul Beregi, MD, PhD
    • Sub-Investigator: Cornelia Freitag, MD
    • Sub-Investigator: Liliane Metge, MD
    • Sub-Investigator: Xavier Stefanovic, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Routine Imaging; Patients randomized to this arm will have routine post-stroke/TIA imaging assessments. Intervention: Routine Imaging Assessment	Other: Routine Imaging Assessment; 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.
Experimental: LDWBA first; 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. Intervention: LDWBA first followed by Routine Imaging Assessment if required.	Other: Routine Imaging Assessment; 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.; Device: LDWBA first (CT scan); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	between day 1 and hospital discharge (expected maximum of two weeks)
Length of hospital stay (h)	The units are given in hours even for long stays.	hospital discharge (expected maximum of two weeks)
Patient pathway: the number of imaging exams required		Month 1
Patient pathway: the types of imaging exams required		Month 1
Total irradiation (mSv) during patient pathway		Month 1
For contrast injections during the patient pathway: total grams of iodine injected		Month 1
Number of atherosclerotic sites detected / number of imaging examinations performed		Month 1
The presence / absence of tight stenosis on the supra aortic arteries		Month 1
The presence / absence of an occlusion on the supra aortic arteries		Month 1
The presence / absence of a dissection on the supra aortic arteries		Month 1
The number of atherosclerotic lesions in the aortic arch		Month 1
For each atherosclerotic lesion in the aortic arch: plaque thickness (mm)		Month 1
For each atherosclerotic lesion in the aortic arch: presence/absence of crevices		Month 1
For each atherosclerotic lesion in the aortic arch: presence/absence of plaque thromboses		Month 1
Detection of patent foramen ovale (yes/no)		Month 1
Presence / absence of a thrombus or a circulatory stasis in the left atrium		Month 1
Extent of atherosclerosis: affects the coronary arteries? yes/no		Month 1
Extent of atherosclerosis: affects the aortic valve? yes/no		Month 1
Extent of atherosclerosis: affects the aortic arch? yes/no		Month 1
Extent of atherosclerosis: affects the abdominal aorta? yes/no		Month 1
Extent of atherosclerosis: affects the renal arteries? yes/no		Month 1
Extent of atherosclerosis: affects digestive arteries? yes/no		Month 1
Extent of atherosclerosis: affects iliac or common femoral arteries? yes/no		Month 1
Extent of atherosclerosis: affects supra aortic trunks? yes/no		Month 1
For each detected incidentaloma: volume (mm^3)		Month 1
The thickness of the left atrial wall		Month 1
Presence / absence of paroxysmal atrial fibrillation		36 months
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)	36 months
Survival (yes/no)		12 months
Survival (yes/no)		36 months
EQ-5D-5L questionnaire		12 months
EQ-5D-5L questionnaire		36 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Francesco Macri, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): June 12, 2026

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (Estimated): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Stroke; Ischemic Attack, Transient
• Other Study ID Numbers: AOI/2014/FM-01; 2015-A01600-49 (Other Identifier: RCB number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No