Status:
RECRUITING
An Imaging Study of Polyvascular Disease
Lead Sponsor:
Harbin Medical University
Conditions:
Polyvascular Disease
Eligibility:
All Genders
18+ years
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 promo...
Eligibility Criteria
Inclusion
- Task 1:
- Patients with coronary artery disease (≥50% stenosis in any coronary artery on coronary angiography)
- Age ≥18 years old
- Proposed OCT-IVUS integrated imaging system
- able to provide written informed consent prior to the start of any procedures related to the study.
- Task 2:
- 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)
- Age ≥ 18 years
- able to provide written informed consent prior to the start of any procedures related to the study.
Exclusion
- Task 1:
- severely tortuous/calcified coronary arteries with anticipated difficulty in completing the OCT-IVUS integrated imaging system
- uncontrolled congestive heart failure or acute left heart failure;plan
- claustrophobia;
- left main stem occlusion;
- proposed coronary artery bypass grafting (CABG);
- uncontrolled severe ventricular arrhythmia;
- active bleeding or severe bleeding tendency;
- acute stroke;
- patients with hemodynamic instability or unstable cardiac electrical activity (including shock) ;
- severe renal insufficiency and/or anuria, except in cases where dialysis treatment has been planned;
- contraindications to the application of contrast media;
- patients who are severely uncooperative due to psychiatric or serious systemic illness;
- Patients who, in the opinion of the investigator, are unsuitable for participation in the study.
- Task 2:
- patients who are unable to comply with the follow-up schedule;
- uncontrolled congestive heart failure or acute left heart failure;
- patients with a life expectancy of less than 6 months;
- left main stem occlusion;
- proposed coronary artery bypass grafting (CABG);
- uncontrolled severe ventricular arrhythmia;
- active bleeding or severe bleeding tendency;
- patients with hemodynamic instability or unstable cardiac electrical activity (including shock) ;
- severe renal insufficiency and/or anuria, except in cases where dialysis treatment has been planned;
- contraindications to the application of contrast media;
- patients who are severely uncooperative due to psychiatric or serious systemic illness;
- patients who, in the opinion of the investigator, are not suitable for participation in the study.
Key Trial Info
Start Date :
October 18 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT06016608
Start Date
October 18 2023
End Date
December 31 2025
Last Update
December 27 2024
Active Locations (1)
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1
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000