NCT06016608
Recruiting
Not Applicable
Early Screen, Systematic Evaluation and Risk Warning of Polyvascular Disease Based on Multi-modality Imaging
Harbin Medical University1 site in 1 country1,100 target enrollmentOctober 18, 2023
ConditionsPolyvascular Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Polyvascular Disease
- Sponsor
- Harbin Medical University
- Enrollment
- 1100
- Locations
- 1
- Primary Endpoint
- Task1: MACE
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
- Establish a multimodality imaging database for PVD, improve the one-stop screening process for early PVD based on artificial intelligence, build a full-cycle control information platform, and promote the construction and standardization of a multidisciplinary co-morbidity and co-management diagnosis and treatment model.
- Based on non-invasive, zero-contrast ocular OCTA combined with one-stop CTA imaging of the heart and brain, construct an integrated "eye-heart-brain" early warning model for PVD, and explore a potential non-invasive and convenient early warning system for PVD.
- Based on the multi-omics, investigate EVs-mediated intercellular communication network, elucidate the roles and regulatory mechanisms of EVs in the development of PVD, search for potential targets for intervention, and construct an artificial intelligence-based "pan-vascular score" risk assessment system based on the combination of multi-modality imaging and multi-omics biomarkers.
Investigators
Yu Bo
Director
Harbin Medical University
Eligibility Criteria
Inclusion Criteria
- •Patients with coronary artery disease (≥50% stenosis in any coronary artery on coronary angiography)
- •Age ≥18 years old
- •Proposed OCT-IVUS integrated imaging system
- •able to provide written informed consent prior to the start of any procedures related to the study.
- •patients with coronary artery disease (coronary angiography reveals ≥50% degree of stenosis in any coronary artery) and patients with stroke or TIA (confirmed by a neurologist)
- •Age ≥ 18 years
- •able to provide written informed consent prior to the start of any procedures related to the study.
Exclusion Criteria
- •severely tortuous/calcified coronary arteries with anticipated difficulty in completing the OCT-IVUS integrated imaging system
- •uncontrolled congestive heart failure or acute left heart failure;plan
- •claustrophobia;
- •left main stem occlusion;
- •proposed coronary artery bypass grafting (CABG);
- •uncontrolled severe ventricular arrhythmia;
- •active bleeding or severe bleeding tendency;
- •acute stroke;
- •patients with hemodynamic instability or unstable cardiac electrical activity (including shock) ;
- •severe renal insufficiency and/or anuria, except in cases where dialysis treatment has been planned;
Outcomes
Primary Outcomes
Task1: MACE
Time Frame: 1 year
All cause death, stroke, myocardial reinfarction, unplanned revascularization, lower extremity artery disease
Task2: Plaque characteristics
Time Frame: 1 year
Plaque morphology on OCT
Study Sites (1)
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