An Imaging Study of Polyvascular Disease

Early Screen, Systematic Evaluation and Risk Warning of Polyvascular Disease Based on Multi-modality Imaging

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.

Study Overview

• Status: Recruiting
• Conditions: Polyvascular Disease
• Intervention / Treatment: Diagnostic test: Magnetic Resonance Angiography, Ocular OCTA, CT Angiography

• Study Type: Observational
• Enrollment (Estimated): 1100

Contacts and Locations

• Study Contact: Name: Minghao Liu, MD.; Phone Number: +8613764166251; Email: baiyuedao@alumni.sjtu.edu.cn

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • The Second Affiliated Hospital of Harbin Medical University
      • Contact: Minghao Liu, MD.; Phone Number: +8613764166251; Email: baiyuedao@alumni.sjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with polyvascular disease in the 2nd Affiliated Hospital of Harbin Medical University

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Polyvascular disease	Diagnostic test: Magnetic Resonance Angiography, Ocular OCTA, CT Angiography; Magnetic Resonance Angiography of intracranial artery, carotid artery, renal artery and lower extremity artery, CT angiography of coronary artery or intracranial artery

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Harbin Medical University
• Investigators: Principal Investigator: Haibo Jia, MD. Ph.D, The Second Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ChiCTR2300074638

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No