An Imaging Study of Polyvascular Disease

• Sponsor: Harbin Medical University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06016608
• Collaborator: (none)
• Enrollment: 1,100
• Location: 1
• Anticipated Duration (Months): 28.1
• Patients Per Site Per Month: 39.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polyvascular Disease	Diagnostic Test: Magnetic Resonance Angiography, Ocular OCTA, CT Angiography

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Early Screen, Systematic Evaluation and Risk Warning of Polyvascular Disease Based on Multi-modality Imaging
• Anticipated Study Start Date: Aug 30, 2023
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Polyvascular disease	Diagnostic Test: Magnetic 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

Outcome Measures

Primary Outcome Measures

1. Task1: MACE [1 year]

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

2. Task2: Plaque characteristics [1 year]

   Plaque morphology on OCT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150000

Sponsors and Collaborators

• Harbin Medical University

Investigators

• Principal Investigator: Haibo Jia, MD. Ph.D, The Second Affiliated Hospital of Harbin Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yu Bo, Director, Harbin Medical University
• ClinicalTrials.gov Identifier: NCT06016608
• Other Study ID Numbers: ChiCTR2300074638
• First Posted: Aug 29, 2023
• Last Update Posted: Aug 29, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 29, 2023