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Clinical Trials/NCT06016608
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

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

  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.
Registry
clinicaltrials.gov
Start Date
October 18, 2023
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Harbin Medical University
Responsible Party
Principal Investigator
Principal Investigator

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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