MINOCANCT07182955
Determinants of Cardiorespiratory Fitness and Effects of HIIT in Patients With ANOCA Obstructive Coronary Artery Disease(ANOCA)
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with MINOCA and Shortness of Breath, run by University of Virginia at 1 site in United States.
Trial summary
The main goal is to understand what causes reduced fitness in ANOCA and whether targeted exercise can help improve it. This study aims to better understand why patients with Angina and No Obstructive Coronary Artery Disease (ANOCA) have poor cardiorespiratory fitness and its effect on quality of life. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- MINOCA, Shortness of Breath, Atherosclerotic Heart Disease of Native Coronary Artery
- What is being tested?
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2025to 14 Apr 2026
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85
- ANOCA (Anginal symptoms of chest pain or exertional dyspnea suspected to be from myocardial ischemia Invasive or CT coronary angiogram without obstructive epicardial CAD (≥50% left main or ≥70% other epicardial stenosis or fractional flow reserve ≤0.80)
- Able to use the wearable and participate in a remote exercise program
- Able to participate in intermittent high-intensity training.
- Able to perform cardiopulmonary exercise testing (CPET)
- Able to provide Health-related quality of life questionnaire (HRQOL)
- Participants must be able to understand and provide informed consent in English and complete the study questionnaire in English
Who cannot join
- Systolic heart failure (LVEF <50% or NYHA class III symptoms)
- Prior myocardial infarction, coronary revascularization
- Inability to safely undergo cardiopulmonary exercise testing, based on investigator's judgment
- Pregnancy (due to unknown effects on CPET exercise markers)
- Inability to provide informed consent
- Life expectancy <1 year
Show all 9Show fewer
- Prisoners
- Cognitively impaired
- Non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22908
Rahel Askari, 434-243-7195, rahel.askari@uvahealth.org
Jamieson M Bourque, MD, MHS
About this study
Official title: Determinants of Cardiorespiratory Fitness and Effects of High Intensity Interval Training (HIIT) in Patients With Angina and No Obstructive Coronary Artery Disease (ANOCA)
The main goal is to understand what causes reduced fitness in ANOCA and whether targeted exercise can help improve it.
This study aims to better understand why patients with Angina and No Obstructive Coronary Artery Disease (ANOCA) have poor cardiorespiratory fitness and its effect on quality of life.
Investigators also want to see if a structured high-intensity exercise program (HIIT), done with remote monitoring, can safely improve heart function, fitness, and quality of life in these patients. The Investigators will use a special exercise test called cardiopulmonary exercise testing to look for patterns that can help explain exercise limitations and quality of life in ANOCA before and after a remote high-intensity exercise program.
Read the detailed description
The overall research plan is for 25 subjects with angina and no obstructive coronary artery disease (ANOCA) on invasive or coronary CT angiography (ANOCA Study Population) to undergo cardiopulmonary exercise testing (CPET) to assess exercise workload and hemodynamic variables and health-related quality of life (HRQOL) measurement at baseline, followed by repeat testing after high-intensity interval exercise training for 4 weeks. The investigators will examine the diagnostic role of exercise by determining the relationship between exercise fitness and assessing the degree of cardiac, ventilatory, and muscle impairment on CPET.
Anginal burden and related functional status will be assessed via the Seattle Anginal Questionnaire. Overall functional status will be assessed through the Short form (SF36) and MacNew forms, levels of cardiac anxiety through the Cardiac Anxiety Questionnaire (CAQ), and effects on work absenteeism and presenteeism through the Work Limitations Questionnaire (WLQ). Baseline exercise status will be documented through the Duke Activity Status Index form.
The investigators will identify cardiorespiratory fitness peak oxygen consumption (VO2peak) and CPET phenotype with ANOCA. The investigators hypothesize that patients with ANOCA will have reduced VO2 peak and heterogeneous CPET phenotypes with substantial and varying contributions of cardiac, ventilatory, and muscle impairment. Phenotyping of determinants of exercise intolerance will be carried out using the following CPET parameters: cardiac-VO2peak, non-invasive cardiac output with CO2 rebreathing, and O2pulse; ventilatory via VE/VO2and oxygen uptake efficiency slope (OUES); muscle by VE/VCO2 slope, a-vO2 difference, and quadriceps muscle strength on isokinetic dynamometry. The Investigators predict that cardiac impairment will be the most frequent CPET phenotype in ANOCA, and this group will have poor exercise fitness.
The investigators will perform a 4-week high-intensity interval exercise training in 25 patients with ANOCA. The investigators will examine the feasibility of a remote exercise program with ramp exercise thresholds. The investigators predict that exercise program session adherence will be >80% based on preliminary data. The investigators will assess the effect of HIIT on CPET phenotype, improvement in VO2peak in patients with varying CPET phenotypes, model entropy, and HRQOL overall score and specific functional domains. The investigators predict that VO2peak will significantly improve with HIIT.
The exercise protocol for subjects will entail one initial supervised exercise session. All subsequent exercises will be done remotely. Each heart rate monitor will be programmed with heart rate zones that are 85-90% of that subject's angina threshold on the CPET. Subjects will be instructed to start with one 1-minute exercise and one 1-minute rest. The protocol will increase the length of exercise with the goal of getting up to four 4-minute sessions of exercise on three non-consecutive days of the week.
Remote HIIT will be accomplished using Polar heart rate monitoring and the Polar flow application. Patients will receive one supervised, treadmill exercise training session with all other exercise sessions performed remotely (brisk walking).
Participants will be provided with a wrist-based Polar Unite, which measures movement as well as heart rate (green LED) and transmits data to a centralized Polar storage site. Participants will be asked to wear the Polar device every day during the study. In addition, during intervention sessions, participants will be asked to wear the chest stripe to get a more accurate recording of HR to follow the exercise prescription.
Study staff will help set up the Polar watch and Polar Application and will demonstrate how to use them. Subjects will be given one training session in the exercise physiology core lab in which they will be shown how to follow the exercise regimen via their Polar device and also shown how to properly use the equipment.
- Being tested
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Keywords
- ANOCA/MINOCA, High Intensity Interval Training, CPET Phenotype, Cardiorespiratory Fitness
- Medical subject headings
- MINOCA, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAINING WITH OR WITHOUT MEDICATIONBehavioural
Remote 4 weeks of high-intensity interval exercise training on three non-consecutive days of the week.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Remote 4 weeks of high-intensity interval exercise training on three non-consecutive days of the week. Receives: Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine cardiorespiratory fitness (change in VO2max in mL/kg/min) with cardiopulmonary exercise testing (CPET) Phenotype.
The investigators will assess VO2max (mL/kg/min) in 25 patients with ANOCA at the exercise laboratory.
Measured: 4 weeks
Secondary outcomes (2)
Assess Changes in cardio-respiratory fitness (CRF) (VO2max) with High-Intensity Interval Exercise Training (HIIT) in Patients with ANOCA.
The investigators will examine the feasibility of a remote exercise program using ramp exercise thresholds. Based on preliminary data, they predict that adherence to the exercise sessions will exceed 80%. After four weeks of remote exercise, the investigators will reassess cardiorespiratory fitness (VO2max in mL/kg/min) after the HIIT intervention.
Measured: 4 weeks
Health Related Quality Of Life (HRQOL) questionnaire
The investigators will assess the health-related quality of life at baseline, alongside exercise testing, and again four weeks after the completion of the study to evaluate any changes.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start11 Aug 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion14 Apr 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 MINOCAStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamieson Bourque, MD, University of Virginia
- Investigators
- Jamieson M Bourque, MD, MHS, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182955
- Sponsor's protocol ID
- 302240
- Status last verified
- Sep 2025
- First submitted
- 11 Jul 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Angadi SS, Jarrett CL, Sherif M, Gaesser GA, Mookadam F. The effect of exercise training on biventricular myocardial strain in heart failure with preserved ejection fraction. ESC Heart Fail. 2017 Aug;4(3):356-359. doi: 10.1002/ehf2.12149. Epub 2017 Mar 16.
PubMed 28772048Hambrecht R, Walther C, Mobius-Winkler S, Gielen S, Linke A, Conradi K, Erbs S, Kluge R, Kendziorra K, Sabri O, Sick P, Schuler G. Percutaneous coronary angioplasty compared with exercise training in patients with stable coronary artery disease: a randomized trial. Circulation. 2004 Mar 23;109(11):1371-8. doi: 10.1161/01.CIR.0000121360.31954.1F. Epub 2004 Mar 8.
PubMed 15007010
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Cardiorespiratory Fitness and Effects of High Intensity Interval Training (HIIT) in Patients With Angina and No Obstructive Coronary Artery Disease (ANOCA)
- ClinicalTrials.gov ID
- NCT07182955
- Acronym / sponsor ID
- 302240
- Keywords
- ANOCA/MINOCA, High Intensity Interval Training, CPET Phenotype, Cardiorespiratory Fitness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 14 Apr 2026 (estimated)
- First posted
- 19 Sep 2025 (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 main goal is to understand what causes reduced fitness in ANOCA and whether targeted exercise can help improve it.
This study aims to better understand why patients with Angina and No Obstructive Coronary Artery Disease (ANOCA) have poor cardiorespiratory fitness and its effect on quality of life.
Investigators also want to see if a structured high-intensity exercise program (HIIT), done with remote monitoring, can safely improve heart function, fitness, and quality of life in these patients. The Investigators will use a special exercise test called cardiopulmonary exercise testing to look for patterns that can help explain exercise limitations and quality of life in ANOCA before and after a remote high-intensity exercise program.
Detailed description
The overall research plan is for 25 subjects with angina and no obstructive coronary artery disease (ANOCA) on invasive or coronary CT angiography (ANOCA Study Population) to undergo cardiopulmonary exercise testing (CPET) to assess exercise workload and hemodynamic variables and health-related quality of life (HRQOL) measurement at baseline, followed by repeat testing after high-intensity interval exercise training for 4 weeks. The investigators will examine the diagnostic role of exercise by determining the relationship between exercise fitness and assessing the degree of cardiac, ventilatory, and muscle impairment on CPET.
Anginal burden and related functional status will be assessed via the Seattle Anginal Questionnaire. Overall functional status will be assessed through the Short form (SF36) and MacNew forms, levels of cardiac anxiety through the Cardiac Anxiety Questionnaire (CAQ), and effects on work absenteeism and presenteeism through the Work Limitations Questionnaire (WLQ). Baseline exercise status will be documented through the Duke Activity Status Index form.
The investigators will identify cardiorespiratory fitness peak oxygen consumption (VO2peak) and CPET phenotype with ANOCA. The investigators hypothesize that patients with ANOCA will have reduced VO2 peak and heterogeneous CPET phenotypes with substantial and varying contributions of cardiac, ventilatory, and muscle impairment. Phenotyping of determinants of exercise intolerance will be carried out using the following CPET parameters: cardiac-VO2peak, non-invasive cardiac output with CO2 rebreathing, and O2pulse; ventilatory via VE/VO2and oxygen uptake efficiency slope (OUES); muscle by VE/VCO2 slope, a-vO2 difference, and quadriceps muscle strength on isokinetic dynamometry. The Investigators predict that cardiac impairment will be the most frequent CPET phenotype in ANOCA, and this group will have poor exercise fitness.
The investigators will perform a 4-week high-intensity interval exercise training in 25 patients with ANOCA. The investigators will examine the feasibility of a remote exercise program with ramp exercise thresholds. The investigators predict that exercise program session adherence will be >80% based on preliminary data. The investigators will assess the effect of HIIT on CPET phenotype, improvement in VO2peak in patients with varying CPET phenotypes, model entropy, and HRQOL overall score and specific functional domains. The investigators predict that VO2peak will significantly improve with HIIT.
The exercise protocol for subjects will entail one initial supervised exercise session. All subsequent exercises will be done remotely. Each heart rate monitor will be programmed with heart rate zones that are 85-90% of that subject's angina threshold on the CPET. Subjects will be instructed to start with one 1-minute exercise and one 1-minute rest. The protocol will increase the length of exercise with the goal of getting up to four 4-minute sessions of exercise on three non-consecutive days of the week.
Remote HIIT will be accomplished using Polar heart rate monitoring and the Polar flow application. Patients will receive one supervised, treadmill exercise training session with all other exercise sessions performed remotely (brisk walking).
Participants will be provided with a wrist-based Polar Unite, which measures movement as well as heart rate (green LED) and transmits data to a centralized Polar storage site. Participants will be asked to wear the Polar device every day during the study. In addition, during intervention sessions, participants will be asked to wear the chest stripe to get a more accurate recording of HR to follow the exercise prescription.
Study staff will help set up the Polar watch and Polar Application and will demonstrate how to use them. Subjects will be given one training session in the exercise physiology core lab in which they will be shown how to follow the exercise regimen via their Polar device and also shown how to properly use the equipment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONRemote 4 weeks of high-intensity interval exercise training on three non-consecutive days of the week. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-85
- ANOCA (Anginal symptoms of chest pain or exertional dyspnea suspected to be from myocardial ischemia Invasive or CT coronary angiogram without obstructive epicardial CAD (≥50% left main or ≥70% other epicardial stenosis or fractional flow reserve ≤0.80)
- Able to use the wearable and participate in a remote exercise program
- Able to participate in intermittent high-intensity training.
- Able to perform cardiopulmonary exercise testing (CPET)
Key exclusion criteria (9 listed)
- Systolic heart failure (LVEF <50% or NYHA class III symptoms)
- Prior myocardial infarction, coronary revascularization
- Inability to safely undergo cardiopulmonary exercise testing, based on investigator's judgment
- Pregnancy (due to unknown effects on CPET exercise markers)
- Inability to provide informed consent
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 TRAINING WITH OR WITHOUT MEDICATIONRemote 4 weeks of high-intensity interval exercise training on three non-consecutive days of the week. | Behavioural | Exercise |
Primary outcome
Examine cardiorespiratory fitness (change in VO2max in mL/kg/min) with cardiopulmonary exercise testing (CPET) Phenotype.
Time frame: 4 weeks
The investigators will assess VO2max (mL/kg/min) in 25 patients with ANOCA at the exercise laboratory.
2 secondary outcomes
Assess Changes in cardio-respiratory fitness (CRF) (VO2max) with High-Intensity Interval Exercise Training (HIIT) in Patients with ANOCA.
Time frame: 4 weeks
Health Related Quality Of Life (HRQOL) questionnaire
Time frame: 4 Weeks
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 19 Sep 2025.
- Background: PubMed 28772048Angadi SS, Jarrett CL, Sherif M, Gaesser GA, Mookadam F. The effect of exercise training on biventricular myocardial strain in heart failure with preserved ejection fraction. ESC Heart Fail. 2017 Aug;4(3):356-359. doi: 10.1002/ehf2.12149. Epub 2017 Mar 16.
- Background: PubMed 15007010Hambrecht R, Walther C, Mobius-Winkler S, Gielen S, Linke A, Conradi K, Erbs S, Kluge R, Kendziorra K, Sabri O, Sick P, Schuler G. Percutaneous coronary angioplasty compared with exercise training in patients with stable coronary artery disease: a randomized trial. Circulation. 2004 Mar 23;109(11):1371-8. doi: 10.1161/01.CIR.0000121360.31954.1F. Epub 2004 Mar 8.
- Individual participant dataSharing planned: No
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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.
Jamieson M Bourque, MD, MHS principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with MINOCA and Shortness of Breath, run by University of Virginia at 1 site in United States.
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 7 inclusion and 9 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 19 Sep 2025. 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 United States. 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 Rahel Askari (434-243-7195, rahel.askari@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine cardiorespiratory fitness (change in VO2max in mL/kg/min) with cardiopulmonary exercise testing (CPET) Phenotype. (time frame: 4 weeks). 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 NCT07182955, 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 19 Sep 2025.