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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Routine Imaging Assessment
  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.
• Устройство LDWBA first (CT scan)
  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 mot

Первичные конечные точки

• Presence/absence of at least one element requiring specific treatment [Срок оценки: Day 30]

Вторичные конечные точки (12)

• Diagnostic delay (h) [Срок оценки: between day 1 and hospital discharge (expected maximum of two weeks)]
• Length of hospital stay (h) [Срок оценки: hospital discharge (expected maximum of two weeks)]
• Patient pathway: the number of imaging exams required [Срок оценки: Month 1]
• Patient pathway: the types of imaging exams required [Срок оценки: Month 1]
• Total irradiation (mSv) during patient pathway [Срок оценки: Month 1]
• For contrast injections during the patient pathway: total grams of iodine injected [Срок оценки: Month 1]
• Number of atherosclerotic sites detected / number of imaging examinations performed [Срок оценки: Month 1]
• The presence / absence of tight stenosis on the supra aortic arteries [Срок оценки: Month 1]
• The presence / absence of an occlusion on the supra aortic arteries [Срок оценки: Month 1]
• The presence / absence of a dissection on the supra aortic arteries [Срок оценки: Month 1]
• The number of atherosclerotic lesions in the aortic arch [Срок оценки: Month 1]
• For each atherosclerotic lesion in the aortic arch: plaque thickness (mm) [Срок оценки: Month 1]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Франция · 2 центра

• CHRU de Montpellier - Hôpital Gui de Chauliac — Montpellier
• CHRU de Nîmes - Hôpital Universitaire Carémeau — Nîmes

Идентификаторы

NCT: NCT02662751 · AOI/2014/FM-01 · 2015-A01600-49

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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