An interventional study of EXERCISE TRAINING WITH OR WITHOUT MEDICATION in MINOCA, Shortness of Breath and Atherosclerotic Heart Disease of Native Coronary Artery, sponsored by University of Virginia. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by University of Virginia · Not applicable, Interventional, and Other
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.
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.
29 studies on the registry are indexed under MINOCA; 18 are open to participants now.
Browse MINOCA studies →University of Virginia is the lead sponsor of 675 studies on the registry; 138 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Remote 4 weeks of high-intensity interval exercise training on three non-consecutive days of the week.
Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
Remote 4 weeks of high-intensity interval exercise training on three non-consecutive days of the week.
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.
Time frame: 4 weeks
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.
Time frame: 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.
Time frame: 4 Weeks
Plan to share: No
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