Chronic Total Occlusive Lesions CMR Study

Recruiting

• Conditions: Image; Revascularization; Chronic Total Occlusion

• Registration Number: NCT05614180
• Lead Sponsor: Lin Zhao

Brief Summary

This registry will include consecutive patients presenting with at least one chronic total occlusion on coronary angiogram who will be treated by percutaneous coronary intervention in our center. All patients will undergo a non-invasive assessment for myocardial ischemia/viability using cardiac magnetic resonance (CMR) prior to revascularization therapy. Follow up CMR will be repeated in all participants after three months and one year. Additionally, clinical outcomes and quality of life will be evaluated at baseline and at follow-up. Primary objective of this study is to investigate the the reduction in ischemia (as evaluated by follow-up CMR) and the severity of angina according to clinical evaluation (including Seattle Angina Questionnaires \[SAQ\], Canadian Class Score\[CCS\] and 6-mins walking test).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-05
• Study First Submitted QC: 2022-11-05
• Study First Posted: 2022-11-14
• Study Start: 2023-01-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-28
• Last Update Posted: 2023-08-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Age > 18 years
• Presence of at least one untreated CTO at basal angiography (defined as a total occlusion in any major coronary vessel or relevant side branches [reference vessel diameter ≥2.5mm or as judged by two independent interventional cardiologists], with TIMI 0 in the distal segment and at least 3 months old
• Patient has a clinical indication to perform CTO PCI
• Willing to participate and able to understand, read and sign the informed consent document.

Exclusion Criteria

• CMR contraindications
• Contraindications to adenosine or dobutamine
• Severe chronic kidney disease (estimated Glomerular Filtration Rate [eGFR] <60 mL/min/1.73m2 or serum creatinine level >2.5 mg/dL)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in ischemia	3 months; 12 months	Parameters of cardiac magnetic resonance

Secondary Outcome Measures

Name	Time	Method
Rate of target lesion failure (TLF).	12 months	TLF is defined as a composite of: cardiac death, target vessel myocardial infarction (SCAI definition), and clinically driven TLR.
Changes in angina paramteres	3 months; 12 months	Parameters of angina questionnaires.
Change of left ventricular structure and function	3 months; 12 months	Parameters of left ventricular function and structure on cardiac magnetic resonance

Trial Locations

Locations (1)

Beijing anzhen hospital; 🇨🇳 Beijing, Beijing, China