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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Presence/absence of at least one element requiring specific treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Routine Imaging
Patients randomized to this arm will have routine post-stroke/TIA imaging assessments.
Intervention: Routine Imaging Assessment
干预措施: Routine Imaging Assessment (Other)
LDWBA first
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.
干预措施: Routine Imaging Assessment (Other)
LDWBA first
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.
干预措施: LDWBA first (CT scan) (Device)
结局指标
主要结局
Presence/absence of at least one element requiring specific treatment
时间窗: Day 30
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
次要结局
- Survival (yes/no)(36 months)
- Patient pathway: the types of imaging exams required(Month 1)
- Extent of atherosclerosis: affects the aortic arch? yes/no(Month 1)
- Extent of atherosclerosis: affects the abdominal aorta? yes/no(Month 1)
- Extent of atherosclerosis: affects the coronary arteries? yes/no(Month 1)
- Extent of atherosclerosis: affects the aortic valve? yes/no(Month 1)
- Patient pathway: the number of imaging exams required(Month 1)
- Diagnostic delay (h)(between day 1 and hospital discharge (expected maximum of two weeks))
- Length of hospital stay (h)(hospital discharge (expected maximum of two weeks))
- Total irradiation (mSv) during patient pathway(Month 1)
- For contrast injections during the patient pathway: total grams of iodine injected(Month 1)
- Number of atherosclerotic sites detected / number of imaging examinations performed(Month 1)
- The presence / absence of tight stenosis on the supra aortic arteries(Month 1)
- The presence / absence of an occlusion on the supra aortic arteries(Month 1)
- The presence / absence of a dissection on the supra aortic arteries(Month 1)
- The number of atherosclerotic lesions in the aortic arch(Month 1)
- For each atherosclerotic lesion in the aortic arch: plaque thickness (mm)(Month 1)
- For each atherosclerotic lesion in the aortic arch: presence/absence of crevices(Month 1)
- For each atherosclerotic lesion in the aortic arch: presence/absence of plaque thromboses(Month 1)
- Presence / absence of a thrombus or a circulatory stasis in the left atrium(Month 1)
- Detection of patent foramen ovale (yes/no)(Month 1)
- Extent of atherosclerosis: affects the renal arteries? yes/no(Month 1)
- Extent of atherosclerosis: affects digestive arteries? yes/no(Month 1)
- Extent of atherosclerosis: affects iliac or common femoral arteries? yes/no(Month 1)
- Extent of atherosclerosis: affects supra aortic trunks? yes/no(Month 1)
- For each detected incidentaloma: volume (mm^3)(Month 1)
- The thickness of the left atrial wall(Month 1)
- Presence / absence of paroxysmal atrial fibrillation(36 months)
- Presence / absence of a cardiovascular event de novo.(36 months)
- EQ-5D-5L questionnaire(36 months)
- Survival (yes/no)(12 months)
- EQ-5D-5L questionnaire(12 months)