Low-dose whole-body angiography for imaging after stroke or TIA
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
This study is testing whether using a low-dose whole-body angiography can help people who have had a stroke or TIA get diagnosed faster and more accurately compared to standard imaging methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 2 sites (Montpellier and 1 other locations) |
| Trial ID | NCT02662751 on ClinicalTrials.gov |
What this trial studies
This study aims to compare two imaging strategies for patients who have experienced a stroke or transient ischemic attack (TIA). One strategy follows the usual imaging protocols at participating centers, while the other begins with a low-dose whole-body angiography. The study will evaluate the number of clinically significant lesions detected, time to diagnosis, hospitalization duration, and overall diagnostic efficiency. Additionally, it will assess the impact on quality of life and the incidence of new cardiovascular events over a follow-up period of 36 months.
Who should consider this trial
Good fit: Ideal candidates are patients who have had a stroke or TIA within the past 10 days and meet specific diagnostic criteria.
Not a fit: Patients who are currently participating in other biomedical research studies or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster and more accurate diagnosis and treatment for stroke and TIA patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving diagnostic efficiency in stroke management.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier and 1 other locations
- CHRU de Montpellier - Hôpital Gui de Chauliac — Montpellier, France (Recruiting)
- CHRU de Nîmes - Hôpital Universitaire Carémeau — Nîmes, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Francesco Macri, MD
- Email: francesco.macri@chu-nimes.fr
- Phone: +33.(0)6.19.42.18.52
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.