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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05614180
Other study ID # KS2022056
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 20, 2023
Est. completion date December 1, 2025

Study information

Verified date July 2023
Source Beijing Anzhen Hospital
Contact Xu Wang, MD
Phone +8615311765609
Email huaianwangxu@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Percutaneous coronary intervention
Patients with a diagnose of coronary chronic total occlusions will be treated by percutaneous coronary intervention, as indicated by the heart-team.

Locations

Country Name City State
China Beijing anzhen hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Lin Zhao

Country where clinical trial is conducted

China, 

Outcome

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