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Talk Test for Coronary Heart Disease (Talk-Test Trial)

N/A
Recruiting
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is at least 40 years of age
Be older than 18 years old
Must not have
Patient has unstable angina or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy
Patient has ventricular ejection fraction ≤45%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to follow-up at week 12
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if the Talk Test is as effective and safe as the CPET for prescribing exercise to patients post CABG or PCI, who are enrolled in a home-based CR program with virtual exercise training monitoring.

Who is the study for?
This trial is for individuals over 40 who've had a heart bypass or stent placement between 4 to 12 weeks ago. Participants need the ability to perform a CPET, have access to MyChart, email, internet, and a smartphone with fast internet. It's not for those unable to attend follow-ups, already in cardiac rehab programs, or with certain heart conditions like severe valve disease.
What is being tested?
The study is testing if the 'Talk Test' can be as effective and safe as CPET (a type of exercise test) for prescribing home-based exercises after heart surgery. Patients will receive virtual monitoring during their rehabilitation program at home.
What are the potential side effects?
Since this trial involves exercise prescriptions rather than medication, side effects are minimal but may include typical risks associated with starting an exercise regimen post-heart surgery such as discomfort or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a serious heart or lung condition.
Select...
My heart pumps less blood than normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to follow-up at week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to follow-up at week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Exercise capacity
Secondary study objectives
Cardiac Rehab safety
Cardiovascular health indicators - Cholesterol HDL
Cardiovascular health indicators - Cholesterol LDL
+4 more
Other study objectives
Cardiometabolic health indicators - BMI
Cardiometabolic health indicators - Blood pressure
Cardiometabolic health indicators - Body composition
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Talk TestExperimental Treatment1 Intervention
Virtual Cardiac Rehab + Exercise prescription based on the Talk test.
Group II: Cardiopulmonary Exercise TestExperimental Treatment1 Intervention
Virtual Cardiac Rehab + Exercise prescription based on the CPET results.

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
195 Previous Clinical Trials
93,460 Total Patients Enrolled
50 Trials studying Coronary Artery Disease
37,821 Patients Enrolled for Coronary Artery Disease
Andrew Pipe, MDStudy ChairOttawa Heart Institute Research Corporation
8 Previous Clinical Trials
1,769 Total Patients Enrolled
4 Trials studying Coronary Artery Disease
818 Patients Enrolled for Coronary Artery Disease

Media Library

CPET Clinical Trial Eligibility Overview. Trial Name: NCT05157932 — N/A
Coronary Artery Disease Research Study Groups: Talk Test, Cardiopulmonary Exercise Test
Coronary Artery Disease Clinical Trial 2023: CPET Highlights & Side Effects. Trial Name: NCT05157932 — N/A
CPET 2023 Treatment Timeline for Medical Study. Trial Name: NCT05157932 — N/A
~1 spots leftby Dec 2024
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