Clinical trial NCT03295773: Morphologic Evolution and Remodeling of Intracranial Atherosclerosis: A Longitudinal Study by 3D-rotational Angiography
Official title: Morphologic Evolution and Remodeling of Intracranial Atherosclerosis: A Longitudinal Study by 3D-rotational Angiography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Atheroscleroses, Cerebral
Keywords: Ischemic Stroke
3D-rotational angiography
Morphology
Atherosclerosis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Morphologic Evolution and Remodeling of Intracranial Atherosclerosis
timeFrame: Dec, 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Thomas Wai Hong LEUNG, FRCP
role: PRINCIPAL_INVESTIGATOR
References: