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NCT Number: NCT06016608

An Imaging Study of Polyvascular Disease

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Location status: Recruiting

Location contact

Minghao Liu, MD.

CONTACT

[email protected]

+8613764166251

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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:

  • patients who are unable to comply with the follow-up schedule;
  • uncontrolled congestive heart failure or acute left heart failure;
  • patients with a life expectancy of less than 6 months;
  • left main stem occlusion;
  • proposed coronary artery bypass grafting (CABG);
  • uncontrolled severe ventricular arrhythmia;
  • active bleeding or severe bleeding tendency;
  • 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 not suitable for participation in the study.

Treatment and study plan

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

Primary outcomes

  1. Task1: MACE

    Time frame: 1 year

    All cause death, stroke, myocardial reinfarction, unplanned revascularization, lower extremity artery disease

  2. Task2: Plaque characteristics

    Time frame: 1 year

    Plaque morphology on OCT

Study contacts

Contact information is provided by the study sponsor or research team.

Minghao Liu, MD.

CONTACT

[email protected]

+8613764166251

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2023
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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