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RecruitingNCT06016608Updated Dec 27, 2024

An Imaging Study of Polyvascular Disease

An observational study in Polyvascular Disease, sponsored by Harbin Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Harbin Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,100
Ages
18 Years and older
Sex
All
01

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.
02

Conditions studied

  • Polyvascular Disease
03

In context

Lead sponsor

Harbin Medical University is the lead sponsor of 87 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Polyvascular disease

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

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

06

What researchers measure

Primary outcomes

  1. Task1: MACE

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

    Time frame: 1 year

  2. Task2: Plaque characteristics

    Plaque morphology on OCT

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • The Second Affiliated Hospital of Harbin Medical University
    Harbin, Heilongjiang 150000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06016608
Lead sponsor
Harbin Medical University
Responsible party
Yu Bo (Director, Harbin Medical University) — Principal investigator
First posted
Aug 29, 2023
Start date
Oct 18, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Dec 27, 2024

Study contacts

Minghao Liu, MD.
Contact
baiyuedao@alumni.sjtu.edu.cn
+8613764166251
Haibo Jia, MD. Ph.D
principal investigator · The Second Affiliated Hospital of Harbin Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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