Imaging study for polyvascular disease

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

This study is trying to see if new imaging methods and technology can help detect polyvascular disease earlier and better for people at risk.

Quick facts

• Study type: Observational
• Enrollment: 1100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Harbin Medical University (other)
• Locations: 1 site (Harbin, Heilongjiang)
• Trial ID: NCT06016608 on ClinicalTrials.gov

What this trial studies

This observational study aims to establish a multimodality imaging database for polyvascular disease (PVD) and enhance early screening processes using artificial intelligence. It will utilize non-invasive imaging techniques, including ocular OCTA and CTA, to develop an integrated early warning model for PVD. The study also seeks to investigate the roles of extracellular vesicles in PVD development and create a risk assessment system based on multi-omics and imaging biomarkers.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with coronary artery disease characterized by significant stenosis.

Not a fit: Patients with severely tortuous or calcified coronary arteries or those with uncontrolled heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection and management of polyvascular disease, potentially reducing complications and enhancing patient outcomes.

How similar studies have performed: While the approach of integrating multimodal imaging and artificial intelligence is innovative, similar studies have shown promise in improving early detection of vascular diseases.

Eligibility criteria

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.

Where this trial is running

Harbin, Heilongjiang

• The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (RECRUITING)

Study contacts

• Principal investigator: Haibo Jia, MD. Ph.D — The Second Affiliated Hospital of Harbin Medical University
• Study coordinator: Minghao Liu, MD.

Conditions: Polyvascular Disease