Chronic Total Occlusion (CTO)PREHAB-CTONCT06610708
Feasibility of a Cardiac Rehabilitation Program for CTO Patients Before PCI Treatment
A study testing Cardiac Prehabilitation Program in people with Chronic Total Occlusion (CTO), run by Luiz Ybarra at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion (CTO)
- What is being tested?
- Cardiac Prehabilitation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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.
Read the 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
- Conditions
- Chronic Total Occlusion (CTO)
- Being tested
- Cardiac Prehabilitation Program
- Keywords
- CTO, Chronic Total Occlusion, Prehabilitation, Prehab, PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Prehabilitation ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cardiac Prehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Secondary outcomes (5)
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.)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Total Occlusion (CTO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luiz Ybarra
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario, University of Western Ontario, Canada
- Responsible party
- Sponsor-investigator, Luiz Ybarra, London Health Sciences Centre
- Investigators
- Luiz F Ybarra, MD PhD MBA FRCPC, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610708
- Sponsor's protocol ID
- 14458
- Acronym
- PREHAB-CTO
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not part of the study plan/design.
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.
PubMed 29066329Ybarra 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.
PubMed 33523728
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Intervention Rehabilitation to Optimize Patient Selection for Chronic Total Occlusion Percutaneous Coronary Interventions (PREHAB-CTO Study)
- ClinicalTrials.gov ID
- NCT06610708
- Acronym / sponsor ID
- PREHAB-CTO / 14458
- Conditions
- Chronic Total Occlusion (CTO)
- Keywords
- CTO, Chronic Total Occlusion, Prehabilitation, Prehab, PCI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Luiz YbarraUniversity, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario, University of Western Ontario, Canada
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Prehabilitation for CTO Patients | Experimental | Other: Cardiac Prehabilitation ProgramThis 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- Patient aged ≥18 years of age.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Prehabilitation ProgramPatients 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. | Other | Cardiac Prehabilitation for CTO Patients |
Primary outcome
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)
5 secondary outcomes
Effectiveness of the Prehab-CTO PCI Program
Time frame: 2 years
Effectiveness of the Prehab-CTO PCI Program
Time frame: 2 years
Effectiveness of the Prehab-CTO PCI Program
Time frame: 2 years
Effectiveness of the Prehab-CTO PCI Program
Time frame: 2 years
Estimate of the incidence of cardiovascular events in CTO patients undergoing prehab
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Background: PubMed 29066329Ybarra 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.
- Background: PubMed 33523728Ybarra 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.
- Individual participant dataSharing planned: No. Not part of the study plan/design.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiz F Ybarra, MD PhD MBA FRCPC principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Prehabilitation Program in people with Chronic Total Occlusion (CTO), run by Luiz Ybarra at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luiz F Ybarra, MD PhD MBA FRCPC (519-685-8500 ext. 33036, Luiz.Ybarra@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Prehab-CTO PCI program (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06610708, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.