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

Centre Hospitalier Universitaire de Nīmes

Status: Enrolling

Conditions: Ischemic Attack, Transient; Stroke

Treatments: Device: LDWBA first (CT scan); Other: Routine Imaging Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT02662751

2015-A01600-49 (Other Identifier)

AOI/2014/FM-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

260 participants in 2 patient groups

Routine Imaging

Active Comparator group

Description:

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

Treatment:

Other: Routine Imaging Assessment

LDWBA first

Experimental group

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. Intervention: LDWBA first followed by Routine Imaging Assessment if required.

Treatment:

Other: Routine Imaging Assessment

Device: LDWBA first (CT scan)