Performing a Low-dose, Whole-body Angiography as the First Element of an Imaging Assessment Following Stroke / 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
Centre Hospitalier Universitaire de Nīmes
260 participants
Oct 21, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria13
- 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
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Interventions
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.
Locations(2)
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NCT02662751