NCT02662751

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
DEVICE	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.

Timeline

• Start date: 2019-10-21
• Primary completion: 2026-06-12
• Completion: 2026-06-12
• First posted: 2016-01-26
• Last updated: 2025-03-10

Locations

2 sites across 1 country: France