An interventional study of Routine Imaging Assessment and LDWBA first (CT scan) in Stroke and Ischemic Attack, Transient, sponsored by Centre Hospitalier Universitaire de Nīmes. Recruiting at 2 sites in France. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Screening
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 260 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to this arm will have routine post-stroke/TIA imaging assessments. Intervention: Routine Imaging Assessment
Other: Routine Imaging Assessment
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 · Device: LDWBA first (CT scan)
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.
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.
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
Time frame: Day 30
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.
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.
Time frame: hospital discharge (expected maximum of two weeks)
Patient pathway: the number of imaging exams required
Time frame: Month 1
Patient pathway: the types of imaging exams required
Time frame: Month 1
Total irradiation (mSv) during patient pathway
Time frame: Month 1
For contrast injections during the patient pathway: total grams of iodine injected
Time frame: Month 1
Number of atherosclerotic sites detected / number of imaging examinations performed
Time frame: Month 1
The presence / absence of tight stenosis on the supra aortic arteries
Time frame: Month 1
The presence / absence of an occlusion on the supra aortic arteries
Time frame: Month 1
The presence / absence of a dissection on the supra aortic arteries
Time frame: Month 1
The number of atherosclerotic lesions in the aortic arch
Time frame: Month 1
For each atherosclerotic lesion in the aortic arch: plaque thickness (mm)
Time frame: Month 1
For each atherosclerotic lesion in the aortic arch: presence/absence of crevices
Time frame: Month 1
For each atherosclerotic lesion in the aortic arch: presence/absence of plaque thromboses
Time frame: Month 1
Detection of patent foramen ovale (yes/no)
Time frame: Month 1
Presence / absence of a thrombus or a circulatory stasis in the left atrium
Time frame: Month 1
Extent of atherosclerosis: affects the coronary arteries? yes/no
Time frame: Month 1
Extent of atherosclerosis: affects the aortic valve? yes/no
Time frame: Month 1
Extent of atherosclerosis: affects the aortic arch? yes/no
Time frame: Month 1
Extent of atherosclerosis: affects the abdominal aorta? yes/no
Time frame: Month 1
Extent of atherosclerosis: affects the renal arteries? yes/no
Time frame: Month 1
Extent of atherosclerosis: affects digestive arteries? yes/no
Time frame: Month 1
Extent of atherosclerosis: affects iliac or common femoral arteries? yes/no
Time frame: Month 1
Extent of atherosclerosis: affects supra aortic trunks? yes/no
Time frame: Month 1
For each detected incidentaloma: volume (mm^3)
Time frame: Month 1
The thickness of the left atrial wall
Time frame: Month 1
Presence / absence of paroxysmal atrial fibrillation
Time frame: 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)
Time frame: 36 months
Survival (yes/no)
Time frame: 12 months
Survival (yes/no)
Time frame: 36 months
EQ-5D-5L questionnaire
Time frame: 12 months
EQ-5D-5L questionnaire
Time frame: 36 months
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