An Imaging Study of Polyvascular Disease

NCT06016608 | Recruiting

• 1 other identifier: ChiCTR2300074638
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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.

Conditions

Polyvascular Disease

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Polyvascular disease

Diagnostic Test: Magnetic Resonance Angiography, Ocular OCTA, CT Angiography

Interventions

Magnetic Resonance Angiography, Ocular OCTA, CT Angiography DIAGNOSTIC_TEST

Magnetic Resonance Angiography of intracranial artery, carotid artery, renal artery and lower extremity artery, CT angiography of coronary artery or intracranial artery

Polyvascular disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Task 1:
• 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.
• Task 2:
• 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.

You may not qualify if:

• Task 1:
• 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;
• contraindications to the application of contrast media;
• patients who are severely uncooperative due to psychiatric or serious systemic illness;
• Patients who, in the opinion of the investigator, are unsuitable for participation in the study.
• Task 2:

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Angiography; Computed Tomography Angiography

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Diagnostic Techniques, Cardiovascular; Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray

Study Officials

• Haibo Jia, MD. Ph.D

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minghao Liu, MD.

CONTACT

+8613764166251; baiyuedao@alumni.sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 29, 2023
• Study Start: October 18, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)