Cardiac Rehabilitation for Blocked Arteries

(PREHAB-CTO Trial)

Overseen By Luiz F Ybarra, MD PhD MBA FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Luiz Ybarra

Disqualifiers: Severe valvular disease, Pregnancy, Cardiac transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special rehabilitation program for individuals with blocked heart arteries who might need a procedure called PCI. The goal is to determine if this program, which includes exercise, medication, and lifestyle changes, can improve health and possibly reduce the need for the procedure. Participants will follow the program for six months and undergo multiple health assessments. Those experiencing chest pain or similar symptoms due to blocked arteries may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance heart health and reduce invasive procedures.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this cardiac prehabilitation program is safe for patients with blocked arteries?

Research has shown that cardiac rehabilitation programs, like the one being tested, are generally safe and well-received by patients. These programs typically involve exercise and lifestyle changes to enhance heart health. Although specific data on side effects for this program is unavailable, similar programs have demonstrated safety, with patients rarely experiencing serious side effects.

The cardiac pre-hab program is not a medication or surgery. It aims to improve heart function through exercise and lifestyle changes, which generally carry fewer risks than more invasive treatments.

Participants in this trial will receive close monitoring with regular check-ups to ensure safety and address any potential issues. Those considering joining the trial can expect a structured program with support from medical professionals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cardiac Prehabilitation Program because it focuses on preparing patients with blocked arteries, specifically chronic total occlusions, for potential surgical intervention with PCI. Unlike traditional cardiac rehabilitation, which usually occurs after surgery, this program emphasizes improving patients' health before any procedure. It combines personalized exercise routines, medical optimization, and lifestyle changes to boost functional capacity. This proactive approach aims to enhance overall health and potentially reduce the need for more invasive treatments, offering a unique advantage over standard post-operative rehabilitation.

What evidence suggests that the cardiac prehabilitation program is effective for patients with blocked arteries?

Research has shown that cardiac prehabilitation, which includes exercise and breathing training, can greatly improve exercise capacity and quality of life for patients with blocked arteries (CTO). In this trial, participants will undergo a 6-month cardiac prehabilitation program designed to provide these benefits before procedures like PCI, a method to open blocked arteries. By enhancing exercise ability, this program might also reduce the need for PCI. Evidence so far supports that the program can help patients feel better and might delay or avoid more invasive treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

Luiz F Ybarra, MD PhD MBA FRCPC

Principal Investigator

London Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for patients with Chronic Total Occlusion (CTO), which means they have completely blocked arteries. They should be referred for a procedure called PCI but haven't had it yet. The study will check if a special exercise and health program before the treatment can help improve their heart's function.

Inclusion Criteria

I have a complete blockage in a major heart artery.

I need a procedure for a completely blocked artery due to chest pain or signs of heart muscle not getting enough blood.

Exclusion Criteria

I cannot or will not join the study's heart rehab program.

Life expectancy of < 12 months due to non-cardiovascular comorbidities

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-habilitation

Participants undergo a 6-month cardiac rehabilitation program including physical exercise, medical optimization, and lifestyle modifications.

6 months

Initial assessment, ongoing program participation

Assessment and Decision

Participants are reassessed to determine the need for PCI based on improvements in functional capacity.

1 month

Assessment visit

PCI and Post-PCI Assessment

If PCI is performed, participants are assessed one month later for functional capacity improvements.

1 month

Post-PCI assessment visit

Virtual Follow-up

If PCI is not needed, participants are followed virtually for an additional 5 months.

5 months

Virtual follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac Prehabilitation Program

Trial Overview The trial tests a 'pre-hab' cardiac rehabilitation program to see if it can boost patients' fitness levels before they undergo PCI, which is an artery-opening procedure. It also examines whether this pre-hab could reduce the need for PCI by improving patient health over six months.

How Is the Trial Designed?

Group I: Cardiac Prehabilitation for CTO Patients Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Luiz Ybarra

Lead Sponsor

Trials

1

Recruited

70+

Academic Medical Organization of Southwestern Ontario

Collaborator

Trials

17

Recruited

1,600+

University of Western Ontario, Canada

Collaborator

Trials

168

Recruited

320,000+

Published Research Related to This Trial

The cardiac prehabilitation (Prehab) program for patients awaiting elective coronary artery bypass graft (CABG) surgery showed promising results, with participants increasing their walking distance significantly compared to those receiving standard care.

Prehab participants also demonstrated improved gait speed and had a higher enrollment rate in cardiac rehabilitation three months post-surgery, indicating both feasibility and potential benefits for patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation program for elective coronary artery bypass graft surgery patients: a pilot randomized controlled study. Sawatzky, JA., Kehler, DS., Ready, AE., et al.[2022]

Cardiac rehabilitation programs are generally safe and effective for improving the functional activities of patients with cardiac disease, but not all patients require supervised rehabilitation, especially those who were active before their cardiac event.

High-risk patients with low functional capacities (3-5 METs) benefit the most from rehabilitation, while low-risk patients (7-9 METs) may not need the program, indicating that rehabilitation should be tailored based on individual physical and psychological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation programs. Hotta, SS.[2010]

In a study of 180 adult patients awaiting elective cardiac surgery, prehabilitation involving exercise and inspiratory muscle training did not significantly improve pre-operative functional exercise capacity compared to standard care, as measured by the six-minute walk test.

However, patients with sarcopenia in the prehabilitation group showed greater improvements in their walking distance, and the prehabilitation group had significantly better inspiratory muscle strength post-surgery, indicating potential benefits for specific patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of prehabilitation in patients undergoing elective cardiac surgery. Akowuah, EF., Wagnild, JM., Bardgett, M., et al.[2023]

A comprehensive personalized teleprehabilitation program for patients scheduled for elective cardiac surgery aims to reduce major adverse cardiac events (MACE) and improve post-operative outcomes, utilizing a multidisciplinary approach over at least 6 weeks.

The program includes various modules such as exercise training, nutritional support, and psychological assistance, and is designed to address perioperative risk factors, potentially leading to better recovery and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized teleprehabilitation in elective cardiac surgery: a study protocol of the Digital Cardiac Counselling randomized controlled trial. Scheenstra, B., Mohansingh, C., Bongers, BC., et al.[2023]

In a study of 97 patients referred for prehabilitation before coronary artery bypass grafting (CABG), only 49% attended an initial intake visit, highlighting challenges in patient engagement with prehabilitation programs.

Patients who completed prehabilitation showed significantly higher rates of participation in postoperative cardiac rehabilitation and improvements in key health metrics, such as cardiorespiratory fitness and mental health, suggesting that prehabilitation can enhance recovery outcomes for CABG patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An observational study examining utilization of prehabilitation and its association with postoperative cardiac rehabilitation participation and risk factors following coronary artery bypass grafting. Rouleau, CR., Chirico, D., Hauer, T., et al.[2022]

The PrEPS trial is a randomized controlled study involving 180 participants undergoing elective cardiac surgery, aiming to assess the feasibility and impact of a prehabilitation program that includes exercise and inspiratory muscle training on preoperative functional exercise capacity.

The primary outcome will measure changes in functional exercise capacity using the 6-minute walk test, while secondary outcomes will evaluate various factors such as respiratory function, quality of life, and postoperative complications, potentially improving overall patient outcomes before and after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation in elective patients undergoing cardiac surgery: a randomised control trial (THE PrEPS TRIAL) - a study protocol. Akowuah, E., Mathias, A., Bardgett, M., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06610708

Feasibility of a Cardiac Rehabilitation Program for CTO ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11131147/

Procedural Results and Long-term Outcome of Chronic ... The procedural success rate was 50.0% (n=25) for general interventional cardiologists and 90.1% (n=127) for dedicated CTO operators. In-hospital ...

3. withpower.com withpower.com/trial/phase-chronic-total-occlusion-cto-9-2024-0aab9

Cardiac Rehabilitation for Blocked Arteries (PREHAB-CTO ... Research shows that cardiac prehabilitation, which includes exercise and breathing training, can improve exercise capacity and quality of life in patients ...

4. mdpi.com mdpi.com/2077-0383/14/13/4745

Frailty as a Predictor of In-Hospital Outcomes in Patients ... Background/Objectives: Data on the prognostic value of frailty in patients undergoing percutaneous coronary intervention (PCI) for chronic total occlusion ...

5. researchgate.net researchgate.net/publication/393494842_Frailty_as_a_Predictor_of_In-Hospital_Outcomes_in_Patients_Undergoing_Percutaneous_Coronary_Intervention_for_Chronic_Total_Occlusion

(PDF) Frailty as a Predictor of In-Hospital Outcomes in ... Objectives The aim of this study was to describe the performance and outcomes of chronic total occlusion (CTO) percutaneous coronary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10947430/

Long-Term Outcomes: Chronic Total Occlusion Our data show that patients with CTO had higher rates of adverse cardiovascular events than did those with significant CAD without CTO even after adjustment for ...