An Imaging Study of Polyvascular Disease

Recruiting

• Conditions: Polyvascular Disease
• Interventions: Diagnostic Test: Magnetic Resonance Angiography, Ocular OCTA, CT Angiography

• Registration Number: NCT06016608
• Lead Sponsor: Harbin Medical University

Brief Summary

1. 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.

2. 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.

3. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-22
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-08-29
• Study Start: 2023-10-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-22
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

Task 1:

1. Patients with coronary artery disease (≥50% stenosis in any coronary artery on coronary angiography)
2. Age ≥18 years old
3. Proposed OCT-IVUS integrated imaging system
4. able to provide written informed consent prior to the start of any procedures related to the study.

Task 2:

1. 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)
2. Age ≥ 18 years
3. able to provide written informed consent prior to the start of any procedures related to the study.

Exclusion Criteria

Task 1:

1. severely tortuous/calcified coronary arteries with anticipated difficulty in completing the OCT-IVUS integrated imaging system
2. uncontrolled congestive heart failure or acute left heart failure;plan
3. claustrophobia;
4. left main stem occlusion;
5. proposed coronary artery bypass grafting (CABG);
6. uncontrolled severe ventricular arrhythmia;
7. active bleeding or severe bleeding tendency;
8. acute stroke;
9. patients with hemodynamic instability or unstable cardiac electrical activity (including shock) ;
10. severe renal insufficiency and/or anuria, except in cases where dialysis treatment has been planned;
11. contraindications to the application of contrast media;
12. patients who are severely uncooperative due to psychiatric or serious systemic illness;
13. Patients who, in the opinion of the investigator, are unsuitable for participation in the study.

Task 2:

1. patients who are unable to comply with the follow-up schedule;
2. uncontrolled congestive heart failure or acute left heart failure;
3. patients with a life expectancy of less than 6 months;
4. left main stem occlusion;
5. proposed coronary artery bypass grafting (CABG);
6. uncontrolled severe ventricular arrhythmia;
7. active bleeding or severe bleeding tendency;
8. patients with hemodynamic instability or unstable cardiac electrical activity (including shock) ;
9. severe renal insufficiency and/or anuria, except in cases where dialysis treatment has been planned;
10. contraindications to the application of contrast media;
11. patients who are severely uncooperative due to psychiatric or serious systemic illness;
12. patients who, in the opinion of the investigator, are not suitable for participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Polyvascular disease	Magnetic Resonance Angiography, Ocular OCTA, CT Angiography	-

Primary Outcome Measures

Name	Time	Method
Task1: MACE	1 year	All cause death, stroke, myocardial reinfarction, unplanned revascularization, lower extremity artery disease
Task2: Plaque characteristics	1 year	Plaque morphology on OCT

Trial Locations

Locations (1)

The Second Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China