Chronic Total Occlusive Lesions CMR Study

Lin Zhao400 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Chronic Total Occlusion Image Revascularization

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Change in ischemia

Parameters of cardiac magnetic resonance

Time frame: 3 months; 12 months

Secondary Outcomes

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.

Time frame: 12 months

Changes in angina paramteres

Parameters of angina questionnaires.

Time frame: 3 months; 12 months

Change of left ventricular structure and function

Parameters of left ventricular function and structure on cardiac magnetic resonance

Time frame: 3 months; 12 months

Chronic Total Occlusive Lesions CMR Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts