Status:
NOT_YET_RECRUITING
Feasibility of a Cardiac Rehabilitation Program for CTO Patients Before PCI Treatment
Lead Sponsor:
Luiz Ybarra
Collaborating Sponsors:
Academic Medical Organization of Southwestern Ontario
University of Western Ontario, Canada
Conditions:
Chronic Total Occlusion (CTO)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate the feasibility of a cardiac pre-hab program for patients with blocked arteries (CTO) who are referred for PCI treatment. The main questions it aims to a...
Detailed Description
This is an investigator-initiated prospective single-arm single-center feasibility study of a cardiac pre-hab program for CTO patients referred for CTO PCI. All patients who undergo a coronary angiogr...
Eligibility Criteria
Inclusion
- The presence of a chronic total occlusion in at least one major coronary artery (diameter ≥ 2.5mm).
- Patients who have an indication for percutaneous coronary intervention of a CTO, which includes the presence of:
- Angina or anginal-equivalent symptoms and
- Ischemia or viability in the CTO territory
- Patient aged ≥18 years of age.
Exclusion
- Inability or refusal to participate in the study's cardiac rehabilitation program.
- Participation in CR program in the last 1 year.
- Life expectancy of \< 12 months due to non-cardiovascular comorbidities.
- Anatomy deemed unsuitable for CTO PCI.
- Severe left main disease (angiographic stenosis ≥50%; fractional flow reserve ≤0.80; minimal lumen area \<6mm2).
- Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the study period.
- Pregnancy.
- Acute coronary syndrome within two months.
- Canadian Cardiovascular Society Class ≥III angina of recent onset.
- Angina of any class with a rapidly accelerating pattern.
- Cardiac transplant recipient.
- Inability to understand the questionnaires used in the study.
- Patients unable to provide consent for the study.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06610708
Start Date
October 1 2024
End Date
October 1 2026
Last Update
September 24 2024
Active Locations (1)
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1
University Hospital
London, Ontario, Canada, N6A 5A5