Chronic Total Occlusive Lesions CMR Study

Image Clinical Trial

— CTO-CMR  

Official title:

Chronic Total Occlusive Lesions CMR Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614180
• Other study ID #: KS2022056
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Chronic Total Occlusion
• Image
• Revascularization

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