Feasibility of a Cardiac Rehabilitation Program for CTO Patients Before PCI Treatment (PREHAB-CTO)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Total Occlusion (CTO)
• Intervention / Treatment: Other: Cardiac Prehabilitation Program

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

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luiz F Ybarra, MD PhD MBA FRCPC; Phone Number: 33036 519-685-8500; Email: Luiz.Ybarra@lhsc.on.ca
• Study Contact Backup: Name: Shirin Shadpour; Phone Number: 35625 519-685-8500; Email: shirin.shadpour@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 < 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 <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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cardiac Prehabilitation for CTO Patients; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	2 years
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.	2 years
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.	2 years
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.	2 years
Estimate of the incidence of cardiovascular events in CTO patients undergoing prehab	Estimation of the total number of cardiovascular events (including all-cause death, cardiovascular death, stroke, non-fatal myocardial infraction, hospitalization for cardiovascular causes, and unplanned revascularization) occuring during the prehab program. Unit of measure: estimate/count of events	2 years

Collaborators and Investigators

• Sponsor: Luiz Ybarra
• Collaborators: University of Western Ontario, Canada; Academic Medical Organization of Southwestern Ontario
• Investigators: Principal Investigator: Luiz F Ybarra, MD PhD MBA FRCPC, London Health Sciences Centre

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: PCI; Chronic Total Occlusion; Prehabilitation; CTO; Prehab
• Other Study ID Numbers: 14458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not part of the study plan/design.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No