Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-03-07 @ 1:31 AM
Study NCT ID:
NCT02662751
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2015-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performing a Low-dose, Whole-body Angiography as the First Element of an Imaging Assessment Following Stroke / TIA
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VASCU
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-A01600-49 | OTHER | RCB number | View |