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

NCT02662751 | Recruiting

• 2 other identifiers: AOI/2014/FM-012015-A01600-49
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke; Ischemic Attack, Transient

Outcome Measures

Primary Outcomes (1)

• Presence/absence of at least one element requiring specific treatment

  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

  Day 30

Secondary Outcomes (32)

• 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)

• Patient pathway: the number of imaging exams required

  Month 1

• Patient pathway: the types of imaging exams required

  Month 1

• Total irradiation (mSv) during patient pathway

  Month 1

Study Arms (2)

Routine Imaging

ACTIVE COMPARATOR

Patients randomized to this arm will have routine post-stroke/TIA imaging assessments. Intervention: Routine Imaging Assessment

Other: Routine Imaging Assessment

LDWBA first

EXPERIMENTAL

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.

Other: Routine Imaging Assessment; Device: LDWBA first (CT scan)

Interventions

Routine Imaging Assessment 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; Routine Imaging

LDWBA first (CT scan) 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.

LDWBA first

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHRU de Montpellier - Hôpital Gui de Chauliac

Montpellier, 34295, France

RECRUITING

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Francesco Macri, MD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Central Study Contacts

Francesco Macri, MD

CONTACT

+33.(0)6.19.42.18.52; francesco.macri@chu-nimes.fr

Carey Suehs, PhD

CONTACT

+33.(0)4.66.68.67.88; carey.suehs@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: January 26, 2016
• Study Start: October 21, 2019
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): June 12, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

FR (2)