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Recruiting NCT03295773

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

Observational Ischemic Stroke Atheroscleroses, Cerebral

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3DRA.
Who it may be relevant to
Registry conditions: Ischemic Stroke, Atheroscleroses, Cerebral. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test 3DRA

Primary outcome measures

  • Morphologic Evolution and Remodeling of Intracranial Atherosclerosis [Time frame: Dec, 2019]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

Patient with any of the following conditions would be excluded:

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Hong Kong · 1 center
  • Chinese University of Hong Kong — Hong Kong

Identifiers

NCT: NCT03295773 · crec no. 2015.623

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗