Clinical trial NCT02662751: Performing a Low-dose, Whole-body Angiography as the First Element of an Imaging Assessment Following Stroke / TIA
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Ischemic Attack, Transient
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Presence/absence of at least one element requiring specific treatment
timeFrame: Day 30
Secondary outcomes:
measure: Diagnostic delay (h)
timeFrame: between day 1 and hospital discharge (expected maximum of two weeks)
measure: Length of hospital stay (h)
timeFrame: hospital discharge (expected maximum of two weeks)
measure: Patient pathway: the number of imaging exams required
timeFrame: Month 1
measure: Patient pathway: the types of imaging exams required
timeFrame: Month 1
measure: Total irradiation (mSv) during patient pathway
timeFrame: Month 1
measure: For contrast injections during the patient pathway: total grams of iodine injected
timeFrame: Month 1
measure: Number of atherosclerotic sites detected / number of imaging examinations performed
timeFrame: Month 1
measure: The presence / absence of tight stenosis on the supra aortic arteries
timeFrame: Month 1
measure: The presence / absence of an occlusion on the supra aortic arteries
timeFrame: Month 1
measure: The presence / absence of a dissection on the supra aortic arteries
timeFrame: Month 1
measure: The number of atherosclerotic lesions in the aortic arch
timeFrame: Month 1
measure: For each atherosclerotic lesion in the aortic arch: plaque thickness (mm)
timeFrame: Month 1
measure: For each atherosclerotic lesion in the aortic arch: presence/absence of crevices
timeFrame: Month 1
measure: For each atherosclerotic lesion in the aortic arch: presence/absence of plaque thromboses
timeFrame: Month 1
measure: Detection of patent foramen ovale (yes/no)
timeFrame: Month 1
measure: Presence / absence of a thrombus or a circulatory stasis in the left atrium
timeFrame: Month 1
measure: Extent of atherosclerosis: affects the coronary arteries? yes/no
timeFrame: Month 1
measure: Extent of atherosclerosis: affects the aortic valve? yes/no
timeFrame: Month 1
measure: Extent of atherosclerosis: affects the aortic arch? yes/no
timeFrame: Month 1
measure: Extent of atherosclerosis: affects the abdominal aorta? yes/no
timeFrame: Month 1
measure: Extent of atherosclerosis: affects the renal arteries? yes/no
timeFrame: Month 1
measure: Extent of atherosclerosis: affects digestive arteries? yes/no
timeFrame: Month 1
measure: Extent of atherosclerosis: affects iliac or common femoral arteries? yes/no
timeFrame: Month 1
measure: Extent of atherosclerosis: affects supra aortic trunks? yes/no
timeFrame: Month 1
measure: For each detected incidentaloma: volume (mm^3)
timeFrame: Month 1
measure: The thickness of the left atrial wall
timeFrame: Month 1
measure: Presence / absence of paroxysmal atrial fibrillation
timeFrame: 36 months
measure: Presence / absence of a cardiovascular event de novo.
timeFrame: 36 months
measure: Survival (yes/no)
timeFrame: 12 months
measure: Survival (yes/no)
timeFrame: 36 months
measure: EQ-5D-5L questionnaire
timeFrame: 12 months
measure: EQ-5D-5L questionnaire
timeFrame: 36 months
Other outcomes:
Locations:
city: Montpellier Cedex 5
country: France
facility: CHRU de Montpellier - Hôpital Gui de Chauliac
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Francesco Macri, MD
role: STUDY_DIRECTOR
References: