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

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Routine Imaging Assessment Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Routine Imaging
    Description: Patients randomized to this arm will have routine post-stroke/TIA imaging assessments. Intervention: Routine Imaging Assessment
    ARM 2: Kind: Experimental
    Label: LDWBA first
    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.
  • LDWBA first (CT scan) Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: LDWBA first
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Screening
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Presence/absence of at least one element requiring specific treatment Day 30 No
Secondary Diagnostic delay (h) between day 1 and hospital discharge (expected maximum of two weeks) No
Secondary Length of hospital stay (h) hospital discharge (expected maximum of two weeks) No
Secondary Patient pathway: the number of imaging exams required Month 1 No
Secondary Patient pathway: the types of imaging exams required Month 1 No
Secondary Total irradiation (mSv) during patient pathway Month 1 Yes
Secondary For contrast injections during the patient pathway: total grams of iodine injected Month 1 Yes
Secondary Number of atherosclerotic sites detected / number of imaging examinations performed Month 1 No
Secondary The presence / absence of tight stenosis on the supra aortic arteries Month 1 No
Secondary The presence / absence of an occlusion on the supra aortic arteries Month 1 No
Secondary The presence / absence of a dissection on the supra aortic arteries Month 1 No
Secondary The number of atherosclerotic lesions in the aortic arch Month 1 No
Secondary For each atherosclerotic lesion in the aortic arch: plaque thickness (mm) Month 1 No
Secondary For each atherosclerotic lesion in the aortic arch: presence/absence of crevices Month 1 No
Secondary For each atherosclerotic lesion in the aortic arch: presence/absence of plaque thromboses Month 1 No
Secondary Detection of patent foramen ovale (yes/no) Month 1 No
Secondary Presence / absence of a thrombus or a circulatory stasis in the left atrium Month 1 No
Secondary Extent of atherosclerosis: affects the coronary arteries? yes/no Month 1 No
Secondary Extent of atherosclerosis: affects the aortic valve? yes/no Month 1 No
Secondary Extent of atherosclerosis: affects the aortic arch? yes/no Month 1 No
Secondary Extent of atherosclerosis: affects the abdominal aorta? yes/no Month 1 No
Secondary Extent of atherosclerosis: affects the renal arteries? yes/no Month 1 No
Secondary Extent of atherosclerosis: affects digestive arteries? yes/no Month 1 No
Secondary Extent of atherosclerosis: affects iliac or common femoral arteries? yes/no Month 1 No
Secondary Extent of atherosclerosis: affects supra aortic trunks? yes/no Month 1 No
Secondary For each detected incidentaloma: volume (mm^3) Month 1 No
Secondary The thickness of the left atrial wall Month 1 No
Secondary Presence / absence of paroxysmal atrial fibrillation 36 months No
Secondary Presence / absence of a cardiovascular event de novo. 36 months No
Secondary Survival (yes/no) 12 months No
Secondary EQ-5D-5L questionnaire 12 months No

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