Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610708
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Feasibility of a Cardiac Rehabilitation Program for CTO Patients Before PCI Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pre-Intervention Rehabilitation to Optimize Patient Selection for Chronic Total Occlusion Percutaneous Coronary Interventions PREHAB-CTO Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREHAB-CTO
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 patients39 functional capacity before PCI Does the pre-hab program impact the need for PCI based on improvements in patients39 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
Can the pre-hab program improve patients39 functional capacity before PCI Does the pre-hab program impact the need for PCI based on improvements in patients39 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 indicatedAssessment 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None