Clinical trial NCT06610708: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Total Occlusion (CTO)
Keywords: CTO
Chronic Total Occlusion
Prehabilitation
Prehab
PCI
Lead sponsor: London Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Academic Medical Organization of Southwestern Ontario
name: University of Western Ontario, Canada
First posted: 2024-09-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 answer are:

Can the pre-hab program improve patients\&#39; functional capacity before PCI? Does the pre-hab program impact the need for PCI based on improvements in patients\&#39; 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

Eligibility criteria: Inclusion Criteria:

1. The presence of a chronic total occlusion in at least one major coronary artery (diameter ≥ 2.5mm).
2. Patients who have an indication for percutaneous coronary intervention of a CTO, which includes the presence of:

   1. Angina or anginal-equivalent symptoms and
   2. Ischemia or viability in the CTO territory
3. Patient aged ≥18 years of age.

Exclusion Criteria:

1. Inability or refusal to participate in the study's cardiac rehabilitation program.
2. Participation in CR program in the last 1 year.
3. Life expectancy of \&lt; 12 months due to non-cardiovascular comorbidities.
4. Anatomy deemed unsuitable for CTO PCI.
5. Severe left main disease (angiographic stenosis ≥50%; fractional flow reserve ≤0.80; minimal lumen area \&lt;6mm2).
6. Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the study period.
7. Pregnancy.
8. Acute coronary syndrome within two months.
9. Canadian Cardiovascular Society Class ≥III angina of recent onset.
10. Angina of any class with a rapidly accelerating pattern.
11. Cardiac transplant recipient.
12. Inability to understand the questionnaires used in the study.
13. Patients unable to provide consent for the study.

Primary outcomes:
measure: Feasibility of the Prehab-CTO PCI program
timeFrame: 2 years
Secondary outcomes:
measure: Effectiveness of the Prehab-CTO PCI Program
timeFrame: 2 years
measure: Effectiveness of the Prehab-CTO PCI Program
timeFrame: 2 years
measure: Effectiveness of the Prehab-CTO PCI Program
timeFrame: 2 years
measure: Effectiveness of the Prehab-CTO PCI Program
timeFrame: 2 years
measure: Estimate of the incidence of cardiovascular events in CTO patients undergoing prehab
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: Canada
facility: University Hospital
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Luiz F Ybarra, MD PhD MBA FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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, Tsuchikane E, Virmani R, Walsh SJ, Werner GS, Yamane M, Stone GW, Rinfret S, Stone GW; Chronic Total Occlusion Academic Research Consortium. Definitions and Clinical Trial Design Principles for Coronary Artery Chronic Total Occlusion Therapies: CTO-ARC Consensus Recommendations. Circulation. 2021 Feb 2;143(5):479-500. doi: 10.1161/CIRCULATIONAHA.120.046754. Epub 2021 Feb 1.