Skip to content

An Imaging Study of Polyvascular Disease

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06016608
Enrollment
1100
Registered
2023-08-29
Start date
2023-10-18
Completion date
2025-12-31
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyvascular Disease

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.

Interventions

DIAGNOSTIC_TESTMagnetic 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

Sponsors

Harbin Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Task1: MACE1 yearAll cause death, stroke, myocardial reinfarction, unplanned revascularization, lower extremity artery disease
Task2: Plaque characteristics1 yearPlaque morphology on OCT

Countries

China

Contacts

Primary ContactMinghao Liu, MD.
baiyuedao@alumni.sjtu.edu.cn+8613764166251

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026