Feasibility of a Cardiac Rehabilitation Program for CTO Patients Before PCI Treatment

Official title

Pre-Intervention Rehabilitation to Optimize Patient Selection for Chronic Total Occlusion Percutaneous Coronary Interventions (PREHAB-CTO Study)

Overview

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.

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 angiogram at the London Health Sciences Centre (LHSC) or who are referred to the LHSC CTO PCI program for the CTO PCI procedure within 1 year, will be screened for enrolment. Those who consent to participate in the trial will be referred to the Cardiac Rehabilitation and Secondary Prevention (CRSP) program for a period of cardiac rehabilitation (CR) prior to performing CTO PCI procedure (termed 'pre-hab'). Physical exam, prior history of medications, quality of life questionnaires and blood work will be performed at baseline during their initial pre-hab clinic consultation (Assessment 1). 6 months of pre-hab and medical optimization will be then initiated. After 6 months at Assessment 2 a repeat MIBI and functional Capacity will be reassessed and compare with baseline if there has been any improvement. Based on them, the need for CTO PCI will be redetermined. If CTO PCI is still indicated,(Assessment 3a) after one month of CTO-PCI will be performed to assess improvement in functional capacity.

On the other hand, if CTO-PCI is not required after 6 months the participant will be followed virtually by Cardiac Rehab for 5 months. A final Assessment 4 will be made at 6 month in both instances

Interventions

• Other Cardiac Prehabilitation Program
  Patients 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

Primary outcome measures

• Feasibility of the Prehab-CTO PCI program [Time frame: 2 years]

Secondary outcome measures (5)

• Effectiveness of the Prehab-CTO PCI Program [Time frame: 2 years]
• Effectiveness of the Prehab-CTO PCI Program [Time frame: 2 years]
• Effectiveness of the Prehab-CTO PCI Program [Time frame: 2 years]
• Effectiveness of the Prehab-CTO PCI Program [Time frame: 2 years]
• Estimate of the incidence of cardiovascular events in CTO patients undergoing prehab [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• University Hospital — London

Publications

• Ybarra LF, Dautov R, Gibrat C, Dandona S, Rinfret S. Midterm Angina-Related Quality of Life Benefits After Percutaneous Coronary Intervention of Chronic Total Occlusions. Can J Cardiol. 2017 Dec;33(12):1668-1674. doi: 10.1016/j.cjca.2017.08.008. Epub 2017 Aug 19. PMID 29066329
• Ybarra LF, Rinfret S, Brilakis ES, Karmpaliotis D, Azzalini L, Grantham JA, Kandzari DE, Mashayekhi K, Spratt JC, Wijeysundera HC, Ali ZA, Buller CE, Carlino M, Cohen DJ, Cutlip DE, De Martini T, Di Mario C, Farb A, Finn AV, Galassi AR, Gibson CM, Hanratty C, Hill JM, Jaffer FA, Krucoff MW, Lombardi WL, Maehara A, Magee PFA, Mehran R, Moses JW, Nicholson WJ, Onuma Y, Sianos G, Sumitsuji S, Tsuchik PMID 33523728

Identifiers

NCT: NCT06610708 · 14458

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗