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NCT Number: NCT06610708

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

London, Ontario, N6A 5A5, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of the Prehab-CTO PCI program

    Time frame: 2 years

    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)

Secondary outcomes

  1. Effectiveness of the Prehab-CTO PCI Program

    Time frame: 2 years

    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. Effectiveness of the Prehab-CTO PCI Program

    Time frame: 2 years

    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.

  3. Effectiveness of the Prehab-CTO PCI Program

    Time frame: 2 years

    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.

  4. Effectiveness of the Prehab-CTO PCI Program

    Time frame: 2 years

    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.

  5. Estimate of the incidence of cardiovascular events in CTO patients undergoing prehab

    Time frame: 2 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Luiz F Ybarra, MD PhD MBA FRCPC

CONTACT

[email protected]

519-685-8500 ext. 33036

Shirin Shadpour

CONTACT

[email protected]

519-685-8500 ext. 35625

Sponsors and collaborators

Lead sponsor

Luiz Ybarra

Other

Collaborators

  • Academic Medical Organization of Southwestern Ontario
  • University of Western Ontario, Canada

Registry information

Official study title

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

Acronym: PREHAB-CTO

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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