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

NCT06610708 | Not Yet Recruiting

• 1 other identifier: 14458
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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\' 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.

Conditions

Chronic Total Occlusion (CTO)

Keywords

CTO; Chronic Total Occlusion; Prehabilitation; Prehab; PCI

Outcome Measures

Primary Outcomes (1)

• 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)

  2 years

Secondary Outcomes (5)

• Effectiveness of the Prehab-CTO PCI Program

  2 years

• Effectiveness of the Prehab-CTO PCI Program

  2 years

• Effectiveness of the Prehab-CTO PCI Program

  2 years

• Effectiveness of the Prehab-CTO PCI Program

  2 years

• Estimate of the incidence of cardiovascular events in CTO patients undergoing prehab

  2 years

Study Arms (1)

Cardiac Prehabilitation for CTO Patients

EXPERIMENTAL

This single arm involves a 6-month cardiac pre-habilitation program designed for patients with chronic total occlusions (CTO) who are referred for percutaneous coronary intervention (PCI). Participants receive personalized cardiac rehabilitation, which includes physical exercise, medical optimization, and lifestyle modifications. The program aims to improve functional capacity and overall health before PCI. Assessments will be conducted at the start, after 6 months, and one month post-PCI if performed, with ongoing virtual follow-up for 5 months if PCI is not needed.

Other: Cardiac Prehabilitation Program

Interventions

Cardiac Prehabilitation Program OTHER

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.

Cardiac Prehabilitation for CTO Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luiz Ybarra: lead
• Academic Medical Organization of Southwestern Ontario: collaborator
• University of Western Ontario, Canada: collaborator

Study Sites (1)

University Hospital

London, Ontario, N6A 5A5, Canada

Location

Related Publications (2)

• 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 BACKGROUND

• 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.

  PMID: 33523728 BACKGROUND

Study Officials

• Luiz F Ybarra, MD PhD MBA FRCPC

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luiz F Ybarra, MD PhD MBA FRCPC

CONTACT

519-685-8500; Luiz.Ybarra@lhsc.on.ca

Shirin Shadpour

CONTACT

519-685-8500; shirin.shadpour@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Interventional Cardiologist, Principal Investigator

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 24, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)