Coronary Artery DiseasePACEDNCT06179212
Exercise Testing Protocols for Females and Males With CAD
An observational study of Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Exercise Tests
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2024to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adults older than 18 years of age and have been diagnosed with CAD.
Who may be able to join
- 18 years and older;
- previous CAD diagnosis by a physician;
- can perform a CPET until volitional exhaustion;
- are able to self-ambulate on a treadmill;
- are at least 8 weeks post cardiovascular event or procedure (i.e., percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)); and,
- are able to provide written informed consent.
Who cannot join
- cannot speak, read, write, or understand English or French;
- currently not enrolled in a CR program;
- 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);
- have heart failure with an ejection fraction <45% (indication of possible cardiomyopathy);6
- 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);
- has an ICD;
- is pregnant (sustained vigorous exercise in pregnant women may induce fetal bradycardia)
- is unable to complete submaximal exercise testing (i.e., treadmill, due to musculoskeletal limitations).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Jennifer Reed, PhD, 6136967000, jreed@ottawaheart.ca
Matheus Mistura, MSc, 6136967000 ext. 15944, mmistura@ottawaheart.ca
About this study
Official title: Comparing VO2 Peak Values of Exercise Testing Protocols for Females and Males With CAD
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:
- 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,
- if enjoyment affects the duration of the test, and
- how different exercise test protocols will provide different results of maximal oxygen used by the participant's body during the exercise test.
- Conditions
- Coronary Artery Disease
- Being tested
- Exercise Tests
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TestsDiagnostic test
Patients will complete 4 different cardiopulmonary exercise tests in random order.
| Study group | Role | What they receive |
|---|---|---|
| CPETs | Patients will perform all 4 maximal cardiopulmonary exercise tests in randomized order. The protocols they will perform are: Modified Bruce, modified Naughton, modified Balke and the UOHI Slow Ramp. Receives: Diagnostic Test: Exercise Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Consumption (VO2)
V̇O2 will be measured continuously throughout the treadmill CPET. Peak V̇O2, defined as the highest V̇O2 value that is achieved over a 20-s period during the last minute of the CPET. V̇O2 will be measured throughout each test by a metabolic system (Parvo Medics TrueOne 2400).
Measured: Week 1 to week 4 (measured weekly, at every appointment)
Secondary outcomes (12)
Cardiometabolic health indicators - Blood pressure (BP)
Resting BP (mmHg) will be measured from a seated position using an automated BP monitor. BP will be measured manually using a BP cuff every 2 stages throughout the CPET using an automated BP monitor. Recovery BP will be measured after the completion of the test from a seated position using the automated BP monitor.
Measured: Week 1 to week 4 (measured weekly, at every appointment)
Cardiometabolic health indicators - Heart Rate (HR)
Heart rate will be measured from a seated position using an automated BP monitor. HR will be measured continuously throughout the CPET using a 4-lead electrocardiogram connected to a metabolic system. Recovery HR will be measured after the completion of the test from a seated position using the automated BP monitor.
Measured: Week 1 to week 4 (measured weekly, at every appointment)
Cardiometabolic health indicators - Body mass index
Height (cm) and body mass (kg) will be measured to compute body mass index (kg/m2).
Measured: Week 1 to week 4 (measured weekly, at every appointment)
Cardiometabolic health indicators - Fat mass
Fat mass (kg) and fat-free mass (kg) will be measured using bioelectrical impedance.
Measured: Week 1 to week 4 (measured weekly, at every appointment)
Cardiometabolic health indicators - Waist circumference
Waist circumference will be measured using standardized procedures (2 repeated measures using a tape; in centimeters).
Measured: Week 1 to week 4 (measured weekly, at every appointment)
Cardiometabolic health indicators - Height
Height will be measured using standardized procedures (2 repeated measures using a tape; in centimeters).
Measured: Week 1 to week 4 (measured weekly, at every appointment)
Blood Lactate
Blood lactate (mmol/L) will be measured in the last 30s of every test stage throughout the test using a blood lactate analyzer.
Measured: Week 1 to week 4 (measured weekly, at every appointment)
Rating of perceived exertion (RPE)
Measured at the end of every stage using the validated Borg 6-20 rating of perceived exertion scale. This scale measures how physically exerted an individual feels. 6 is complete rest (i.e., no exertion, ex: sitting in a chair not moving and relaxed), 20 is perceived maximal exertion of effort. These values are perceived measures of effort and will increase as the exercise test progresses and gets harder for the patient.
Measured: Week 1 to week 4 (measured weekly, at every appointment)
Test duration
Measured using portable metabolic system that is connected to a computer. The duration of the test will be recorded.
Measured: Week 1 to week 4 (measured weekly, at every appointment)
Reason for test termination
Reason for test termination will be collected subjectively by asking the patient (i.e., fatigue, muscular limitation, etc.)
Measured: Week 1 to week 4 (collected weekly, at every appointment)
Physical activity enjoyment
This is a subjective questionnaire that measures the extent to which the patient enjoyed participating in the test.
Measured: Week 1 to week 4 (collected weekly, at every appointment)
Most enjoyed test
Using a feedback questionnaire, the test that was most frequently ranked the most enjoyed by patients will be measured
Measured: Week 4 - collected at the patient's last appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 Mar 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Reed, PhD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179212
- Sponsor's protocol ID
- 20230327-01H
- Acronym
- PACED
- Status last verified
- Sep 2026
- First submitted
- 11 Dec 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing VO2 Peak Values of Exercise Testing Protocols for Females and Males With CAD
- ClinicalTrials.gov ID
- NCT06179212
- Acronym / sponsor ID
- PACED / 20230327-01H
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 21 Dec 2023 (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 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:
- 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,
- if enjoyment affects the duration of the test, and
- how different exercise test protocols will provide different results of maximal oxygen used by the participant's body during the exercise test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPETs | – | Diagnostic Test: Exercise TestsPatients will perform all 4 maximal cardiopulmonary exercise tests in randomized order. The protocols they will perform are: Modified Bruce, modified Naughton, modified Balke and the UOHI Slow Ramp. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults older than 18 years of age and have been diagnosed with CAD.
Key inclusion criteria (6 listed)
- 18 years and older;
- previous CAD diagnosis by a physician;
- can perform a CPET until volitional exhaustion;
- are able to self-ambulate on a treadmill;
- are at least 8 weeks post cardiovascular event or procedure (i.e., percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)); and,
Key exclusion criteria (8 listed)
- cannot speak, read, write, or understand English or French;
- currently not enrolled in a CR program;
- 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);
- have heart failure with an ejection fraction <45% (indication of possible cardiomyopathy);6
- 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);
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 |
|---|---|---|
| Exercise TestsPatients will complete 4 different cardiopulmonary exercise tests in random order. | Diagnostic test | CPETs |
Primary outcome
Oxygen Consumption (VO2)
Time frame: Week 1 to week 4 (measured weekly, at every appointment)
V̇O2 will be measured continuously throughout the treadmill CPET. Peak V̇O2, defined as the highest V̇O2 value that is achieved over a 20-s period during the last minute of the CPET. V̇O2 will be measured throughout each test by a metabolic system (Parvo Medics TrueOne 2400).
12 secondary outcomes
Cardiometabolic health indicators - Blood pressure (BP)
Time frame: Week 1 to week 4 (measured weekly, at every appointment)
Cardiometabolic health indicators - Heart Rate (HR)
Time frame: Week 1 to week 4 (measured weekly, at every appointment)
Cardiometabolic health indicators - Body mass index
Time frame: Week 1 to week 4 (measured weekly, at every appointment)
Cardiometabolic health indicators - Fat mass
Time frame: Week 1 to week 4 (measured weekly, at every appointment)
Cardiometabolic health indicators - Waist circumference
Time frame: Week 1 to week 4 (measured weekly, at every appointment)
Cardiometabolic health indicators - Height
Time frame: Week 1 to week 4 (measured weekly, at every appointment)
Blood Lactate
Time frame: Week 1 to week 4 (measured weekly, at every appointment)
Rating of perceived exertion (RPE)
Time frame: Week 1 to week 4 (measured weekly, at every appointment)
Test duration
Time frame: Week 1 to week 4 (measured weekly, at every appointment)
Reason for test termination
Time frame: Week 1 to week 4 (collected weekly, at every appointment)
Physical activity enjoyment
Time frame: Week 1 to week 4 (collected weekly, at every appointment)
Most enjoyed test
Time frame: Week 4 - collected at the patient's last appointment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
Related trials for Coronary Artery Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
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.
Jennifer Reed, PhD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Reed, PhD (613-696-7392, jreed@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Consumption (VO2) (time frame: Week 1 to week 4 (measured weekly, at every appointment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.