Morphologic Evolution and Remodeling of Intracranial Atherosclerosis: A Longitudinal Study by 3D-rotational Angiography

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorChinese University of Hong Kong

About this trial

This study is to elucidate the morphologic evolution and remodeling of ICAD under stringent control of cardiovascular risk factors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient is 30 to 85 years of age, inclusive.

Patients who have an acute infarct in diffusion-weighted MRI compatible with artery-to-artery thrombo-embolism and a relevant intracranial atherosclerotic stenosis ≥60%.

Patient who has no contra-indication for the proposed imaging tests.

Patient understands the purpose and requirements of the study, and has provided an informed consent.

Disqualifiers

Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, Moyamoya disease, small vessel disease or primary angiitis of CNS.

A tandem stenosis >50% at extra-cranial internal carotid artery.

Bleeding propensity: active peptic ulcer disease, major systemic hemorrhage within 30 days, thrombocytopenia (platelets <100 x 109/L), coagulopathy (INR >1.5).

A medical condition that would not allow the patient to adhere to the protocol or complete the study.

Trial population

Patients who have acute cerebral ischemic symptoms attributed to a high-grade (≥60%) stenosis at a middle cerebral artery or intracranial segment of an internal carotid artery (ICA) would be reviewed by neurologists. If their stroke etiology and relevance to ICAD based on clinical syndrome, vascular imaging features and concurrent cardiovascular risks are eligible, they would be invited to join the study.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 3DRA

    Diagnostic test

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: Symptomatic stroke patient1 intervention

Trial outcomes

Primary outcomes

1

Morphologic Evolution and Remodeling of Intracranial Atherosclerosis

The 3DRA images (the disparity in morphological attributes, including surface outline, angulations, plaque volume and distribution) of the patients in pre and post 12 month follow-up would be compared.

Time frame
Dec, 2019

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.