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 answer are:
Can the pre-hab program improve patients\' functional capacity before PCI? Does the pre-hab program impact the need for PCI based on improvements in patients\' health?
Participants will:
Undergo an initial assessment including a physical exam, medication history, quality of life questionnaires, and blood work.
Complete a 6-month cardiac rehabilitation program. Have repeat assessments to evaluate improvements and determine if PCI is still needed.
If PCI is performed, be assessed again one month later for functional capacity improvements.
If PCI is not needed after 6 months, participants will be followed virtually for an additional 5 months.
The presence of a chronic total occlusion in at least one major coronary artery (diameter ≥ 2.5mm).
Angina or anginal-equivalent symptoms and
Ischemia or viability in the CTO territory
Patient aged ≥18 years of age.
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.
Single group
Cardiac Prehabilitation Program
Other interventionPatients begin with a one-on-one assessment by a program cardiologist and a CR nurse, followed by a symptom-limited cardiopulmonary exercise test (CPET) to tailor their exercise regimen. The exercise program, based on the FITT (frequency, intensity, time, and type) principle, includes biweekly sessions either at home or at a commercial gym, with ongoing oversight by SJHC CRSP rehabilitation trainers. Additionally, participants have access to dietary counseling to optimize heart-healthy nutrition.
Feasibility of the Prehab-CTO PCI program
Assessment of eligibility and recruitment rates using a traffic light system (green: feasible, Amber: feasible with modifications, Red: not feasible). Unit of measure: N/A (qualitative assessment)
Effectiveness of the Prehab-CTO PCI Program
Assessment of changes in quality of life, exercise capacity, symptomatology, and depression scores at three time points: after the pre-hab program, after CTO PCI, and at 6 month follow-up. Durability of benefits will also be evaluated. Units of measure: Exercise Capacity: Distance in meters from the 6-Minute Walk Test (A longer distance indicates better exercise capacity, so higher values are associated with better outcomes.)
Effectiveness of the Prehab-CTO PCI Program
Assessment of changes in quality of life, exercise capacity, symptomatology, and depression scores at three time points: after the pre-hab program, after CTO PCI, and at 6 month follow-up. Durability of benefits will also be evaluated. Units of measure: Symptomatology: Seattle Angina Questionnaire score (0-100) with 100 representing the absence of angina and optimal physical function and quality of life related to angina.
Effectiveness of the Prehab-CTO PCI Program
Assessment of changes in quality of life, exercise capacity, symptomatology, and depression scores at three time points: after the pre-hab program, after CTO PCI, and at 6 month follow-up. Durability of benefits will also be evaluated. Units of measure: Depression: PHQ-9 score (0-24) a score from 0 to 24 is produced. Scores of 5, 10, 15 and 20 represent cutpoints for mild, moderate, moderately, and severe depression respectively.
Effectiveness of the Prehab-CTO PCI Program
Assessment of changes in quality of life, exercise capacity, symptomatology, and depression scores at three time points: after the pre-hab program, after CTO PCI, and at 6 month follow-up. Durability of benefits will also be evaluated. Units of measure: Quality of life: EQ-5D score (scale 0-1) 1 represents full health, 0 represents a health state equivalent to death.
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Luiz Ybarra
Lead sponsor
London Health Sciences Centre
Sponsor institution
Academic Medical Organization of Southwestern Ontario
Collaborator
University of Western Ontario, Canada
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
