An Imaging Study of Polyvascular Disease

Polyvascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016608
• Other study ID #: ChiCTR2300074638
• Status: Recruiting
• Start date: October 18, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Harbin Medical University
• Contact: Minghao Liu, MD.
• Phone: +8613764166251
• Email: baiyuedao[@]alumni.sjtu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Polyvascular Disease

Intervention

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

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Task1: MACE	All cause death, stroke, myocardial reinfarction, unplanned revascularization, lower extremity artery disease	1 year
Primary	Task2: Plaque characteristics	Plaque morphology on OCT	1 year