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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03295773
• Other study ID #: crec no. 2015.623
• Status: Recruiting
• Start date: August 22, 2016
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: Chinese University of Hong Kong
• Contact: Thomas Wai Hong LEUNG, FRCP
• Phone: 852-35053593
• Email: drtleung[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

The investigator has conducted extensive research on ICAD by transcranial Doppler ultrasound, CT angiography and perfusion studies, magnetic resonance imaging (MRI) and digital subtraction angiography (DSA) respectively. Currently, the investigator applied 3-dimensional rotational angiogram (3DRA), a selective intra-arterial catheter-based imaging technique that had a superior spatial resolution compared with CT, MRI or DSA in depicting minute (<3mm) angio-architecture. Through 3DRA, the investigator could appreciate the ICAD patho-anatomy from a near-infinite number of planes, analyzing the stroke mechanisms and morphological changes with much improved precision. A neuro-radiologist and a stroke neurologist blind to time sequence will measure the geometric parameters and the luminal narrowing by WASID method.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 30, 2024
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patient is 30 to 85 years of age, inclusive.

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

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

4. Patient understands the purpose and requirements of the study, and has provided an informed consent. Exclusion Criteria:

Patient with any of the following conditions would be excluded:

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

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

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

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

Related Conditions & MeSH terms

• Atheroscleroses, Cerebral
• Atherosclerosis
• Intracranial Arteriosclerosis
• Ischemic Stroke

Intervention

Diagnostic Test:
• 3DRA

Locations

Country	Name	City	State
Hong Kong	Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Dec, 2019