An Imaging Study of Polyvascular Disease

Last updated: December 22, 2024
Sponsor: Harbin Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Magnetic Resonance Angiography, Ocular OCTA, CT Angiography

Clinical Study ID

NCT06016608
ChiCTR2300074638
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Task 1:

  1. Patients with coronary artery disease (≥50% stenosis in any coronary artery oncoronary 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 proceduresrelated to the study.

Task 2:

  1. patients with coronary artery disease (coronary angiography reveals ≥50% degree ofstenosis in any coronary artery) and patients with stroke or TIA (confirmed by aneurologist)

  2. Age ≥ 18 years

  3. able to provide written informed consent prior to the start of any proceduresrelated to the study.

Exclusion

Exclusion Criteria:

Task 1:

  1. severely tortuous/calcified coronary arteries with anticipated difficulty incompleting 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 treatmenthas been planned;

  11. contraindications to the application of contrast media;

  12. patients who are severely uncooperative due to psychiatric or serious systemicillness;

  13. Patients who, in the opinion of the investigator, are unsuitable for participationin 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 treatmenthas been planned;

  10. contraindications to the application of contrast media;

  11. patients who are severely uncooperative due to psychiatric or serious systemicillness;

  12. patients who, in the opinion of the investigator, are not suitable for participationin the study.

Study Design

Total Participants: 1100
Treatment Group(s): 1
Primary Treatment: Magnetic Resonance Angiography, Ocular OCTA, CT Angiography
Phase:
Study Start date:
October 18, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150000
    China

    Active - Recruiting

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