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

NCT ID: NCT02662751

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-21
• Study Completion Date: 2026-06-12

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.

Conditions

Stroke; Ischemic Attack, Transient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Routine Imaging

Patients randomized to this arm will have routine post-stroke/TIA imaging assessments.

Intervention: Routine Imaging Assessment

Group Type: ACTIVE_COMPARATOR

Routine Imaging Assessment

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Routine Imaging Assessment

Intervention Type: OTHER

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.

LDWBA first (CT scan)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: OTHER

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 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesco Macri, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHRU de Montpellier - Hôpital Gui de Chauliac

Montpellier, , France

Site Status: RECRUITING

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Francesco Macri, MD

Role: CONTACT

francesco.macri@chu-nimes.fr

+33.(0)6.19.42.18.52

Carey Suehs, PhD

Role: CONTACT

carey.suehs@chu-nimes.fr

+33.(0)4.66.68.67.88

Other Identifiers

2015-A01600-49

Identifier Type: OTHER

Identifier Source: secondary_id

AOI/2014/FM-01

Identifier Type: -

Identifier Source: org_study_id