NCT06179212 Exercise Testing Protocols for Females and Males With CAD
| NCT ID | NCT06179212 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 54 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 54 participants in total. It began in 2024-03-01 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to determine if the test that allows males to achieve a higher VO2 (a measure of oxygen use during exercise) is different for females. The purpose of this study is to test 4 different exercise testing protocols to compare measured oxygen consumption in females and males with CAD (disease caused by the buildup of plaque in the artery walls which can lead to insufficient amounts of blood, nutrients and oxygen being supplied to the heart). The 4 exercise tests that will be completed on the treadmill are the modified Balke, modified Bruce, modified Naughton and University of Ottawa Heart Institute Slow Ramp protocols. Each test has a different stage duration (the amount of time that the test remains at a pre-determined speed and incline), and incremental increase in speed and incline. The main purpose of this study is to compare VO2 peak (the maximal amount of oxygen utilized during the exercise test) of females and males with CAD in 4 different exercise protocols. For example, the investigators will find out: 1. which exercise protocol is more likely to achieve a higher peak V̇O2 in females and which protocol is more likely to achieve a higher peak V̇O2 in males, 2. if enjoyment affects the duration of the test, and 3. how different exercise test protocols will provide different results of maximal oxygen used by the participant's body during the exercise test.
Eligibility Criteria
Inclusion Criteria: 1. 18 years and older; 2. previous CAD diagnosis by a physician; 3. can perform a CPET until volitional exhaustion; 4. are able to self-ambulate on a treadmill; 5. are at least 8 weeks post cardiovascular event or procedure (i.e., percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)); and, 6. are able to provide written informed consent. Exclusion Criteria: 1. cannot speak, read, write, or understand English or French; 2. currently not enrolled in a CR program; 3. have recently changed (or planning to change) PA levels within the previous 4 weeks (as this may impact the ability to compare outcomes between exercise testing protocols); 4. have heart failure with an ejection fraction \<45% (indication of possible cardiomyopathy);6 5. have an arrythmia (relative contraindication for exercise testing),6 peripheral artery disease, valvular disease, severe aortic stenosis, cardiomyopathy, SCAD and/or COPD (contraindications for maximal exercise testing); 6. has an ICD; 7. is pregnant (sustained vigorous exercise in pregnant women may induce fetal bradycardia) 8. is unable to complete submaximal exercise testing (i.e., treadmill, due to musculoskeletal limitations).
Contact & Investigator
Jennifer Reed, PhD
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT06179212 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06179212 currently recruiting?
Yes, NCT06179212 is actively recruiting participants. Contact the research team at jreed@ottawaheart.ca for enrollment information.
Where is the NCT06179212 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT06179212 clinical trial?
NCT06179212 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Jennifer Reed, PhD at Ottawa Heart Institute Research Corporation. The trial plans to enroll 54 participants.