Coronary Microvascular DiseaseExerciseCMDNCT05810051
Exercise and Coronary Microvascular Disease
A study testing Cardiac rehabilitation in people with Coronary Microvascular Disease, run by CoreAalst BV at 1 site in Belgium.
Trial summary
Exercise CMD is a prospective single-center, open-label, parallel arms randomized controlled trial. This trial aims to assess the impact of cardiac rehabilitation on top of optimal medical therapy on patient-reported outcomes in subjects with coronary microvascular disease and non-obstructive coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Microvascular Disease
- What is being tested?
- Cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Jul 2023to 15 Oct 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non obstructive CAD (diameter stenosis <50% visual or FFR > 0.80)
- Angina at presentation
- Evidence of microvascular dysfunction (IMR ≥ 25)
Who cannot join
- Inability to give consent
- Acute coronary syndrome (ACS)
- Severe valve disease
- Permanent AF
- History of coronary artery bypass grafting (CABG)
- Cardiomyopathies
Show all 9Show fewer
- Intolerance to adenosine
- Hemodynamic instability
- Not able to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Cardiac Rehabilitation Program on Health-related Quality of Life in Patients With Coronary Microvascular Disease.
Exercise CMD is a prospective single-center, open-label, parallel arms randomized controlled trial.
This trial aims to assess the impact of cardiac rehabilitation on top of optimal medical therapy on patient-reported outcomes in subjects with coronary microvascular disease and non-obstructive coronary artery disease.
Read more
Patients will undergo a microvascular assessment using bolus thermodilution techniques and those with criteria for microvascular angina (IMR ≥ 25) will be invited to participate.
Patients will be randomized in a 1:1 ratio to either optimal medical therapy (OMT) or OMT plus a program of cardiac rehabilitations (CR).
After randomization, spiro-ergometry and a SAQ-19 will be performed in all patients. Medical therapy will be standardized in both arms and the CR group will follow 36 sessions of the personalized physical training program of cardiac rehabilitation.
Approximately 204 subjects (102 in each group) will be included at one site (OLV Aalst, Belgium).
Clinical Follow-Up will be planned at 4 months. Patients with CCTA performed in standard of care will be invited for control CCTA 6 +/- 1 month after the invasive procedure.
- Conditions
- Coronary Microvascular Disease
- Being tested
- Cardiac rehabilitation
- Keywords
- Exercise training
- Medical subject headings
- Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationBehavioural
The patients in this arm will be trained for 1 hour, 2 or 3 times per week for 36 sessions. In addition to the training program, the patients also get access to the cardiovascular educational program.
The training (a 1h session) consists of 60% cardiovascular endurance training and 40% resistance training.
| Study group | Role | What they receive |
|---|---|---|
| Optimal medical therapy (OMT) plus a program of cardiac rehabilitation (CR) | Experimental | The intervention group will receive cardiac rehabilitation in addition to lifestyle changes and pharmacological treatment. Receives: Behavioral: Cardiac rehabilitation |
| Optimal medical therapy (OMT) | No intervention | The control group will be randomized to lifestyle changes and pharmacological treatment. In the 7 to 14 days after randomization optimal medical therapy will be started. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in health-related Seattle Angina Questionnaire (SAQ19) between baseline and 4 months
Mean change in health-related quality of life questionnaire as assessed by the Seattle Angina Questionnaire 19, between baseline and 4 months (SAQ-19 Summary Score) with a maximum score of 100 representing a good quality of life.
Measured: 4 Months
Secondary outcomes (6)
Mean change in Seattle Angina Questionnaire (SAQ19)frequency score between baseline and 4 months
Mean change in the Seattle Angina Questionnaire frequency score between baseline and 4 months with a maximum score of 100 representing no angina symptoms.
Measured: 4 Months
Mean change in VO2 peak between baseline and 4 months
Mean change in exercise capacity, as assessed by the peak oxygen consumption (VO2 peak) derived from spiro-ergometry test between baseline and 4 months
Measured: 4 Months
Mean change in VE/VCO2 slope between baseline and 4 months
Mean change in ventilatory efficiency, as assessed by the VE/VCO2 slope derived from spiro-ergometry test, between baseline and 4 months
Measured: 4 Months
Mean change in METS between baseline and 4 months
Mean change in Metabole equivalents (METS) derived from spiro-ergometry test between baseline and 4 months
Measured: 4 Months
Mean change in health related quality of life assessed by the EuroQoL 5 dimensions - 5 levels (EQ5D-5L) Questionnaire between baseline and 4 months
Mean change in health related quality of life as assessed by the EuroQoL 5 dimensions - 5 levels EQ5D-5L Index score between baseline and 4 months with a score of 1 representing a perfect health condition.
Measured: 4 Months
Mean change in vessel volume between patients randomized to exercise and controls
Mean change in vessel volume as assessed by coronary CT angiography between patients randomized to exercise and controls (only for patients with baseline coronary CT angiography).
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start31 Jul 2023
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CoreAalst BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810051
- Sponsor's protocol ID
- CA-021
- Acronym
- ExerciseCMD
- Status last verified
- Jan 2026
- First submitted
- 30 Mar 2023
- Last updated
- 20 Jan 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Cardiac Rehabilitation Program on Health-related Quality of Life in Patients With Coronary Microvascular Disease.
- ClinicalTrials.gov ID
- NCT05810051
- Acronym / sponsor ID
- ExerciseCMD / CA-021
- Conditions
- Coronary Microvascular Disease
- Keywords
- Exercise training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- CoreAalst BVIndustry (pharma, biotech, devices)
- Collaborators
- Abbott Medical Devices
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 12 Apr 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.
Exercise CMD is a prospective single-center, open-label, parallel arms randomized controlled trial.
This trial aims to assess the impact of cardiac rehabilitation on top of optimal medical therapy on patient-reported outcomes in subjects with coronary microvascular disease and non-obstructive coronary artery disease.
Patients will undergo a microvascular assessment using bolus thermodilution techniques and those with criteria for microvascular angina (IMR ≥ 25) will be invited to participate.
Patients will be randomized in a 1:1 ratio to either optimal medical therapy (OMT) or OMT plus a program of cardiac rehabilitations (CR).
After randomization, spiro-ergometry and a SAQ-19 will be performed in all patients. Medical therapy will be standardized in both arms and the CR group will follow 36 sessions of the personalized physical training program of cardiac rehabilitation.
Approximately 204 subjects (102 in each group) will be included at one site (OLV Aalst, Belgium).
Clinical Follow-Up will be planned at 4 months. Patients with CCTA performed in standard of care will be invited for control CCTA 6 +/- 1 month after the invasive procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimal medical therapy (OMT) plus a program of cardiac rehabilitation (CR) | Experimental | Behavioral: Cardiac rehabilitationThe intervention group will receive cardiac rehabilitation in addition to lifestyle changes and pharmacological treatment. |
| Optimal medical therapy (OMT) | No intervention | –The control group will be randomized to lifestyle changes and pharmacological treatment. In the 7 to 14 days after randomization optimal medical therapy will be started. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non obstructive CAD (diameter stenosis <50% visual or FFR > 0.80)
- Angina at presentation
- Evidence of microvascular dysfunction (IMR ≥ 25)
Key exclusion criteria (9 listed)
- Inability to give consent
- Acute coronary syndrome (ACS)
- Severe valve disease
- Permanent AF
- History of coronary artery bypass grafting (CABG)
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 |
|---|---|---|
| Cardiac rehabilitationThe patients in this arm will be trained for 1 hour, 2 or 3 times per week for 36 sessions. In addition to the training program, the patients also get access to the cardiovascular educational program. The training (a 1h session) consists of 60% cardiovascular endurance training and 40% resistance training. | Behavioural | Optimal medical therapy (OMT) plus a program of cardiac rehabilitation (CR) |
Primary outcome
Mean change in health-related Seattle Angina Questionnaire (SAQ19) between baseline and 4 months
Time frame: 4 Months
Mean change in health-related quality of life questionnaire as assessed by the Seattle Angina Questionnaire 19, between baseline and 4 months (SAQ-19 Summary Score) with a maximum score of 100 representing a good quality of life.
6 secondary outcomes
Mean change in Seattle Angina Questionnaire (SAQ19)frequency score between baseline and 4 months
Time frame: 4 Months
Mean change in VO2 peak between baseline and 4 months
Time frame: 4 Months
Mean change in VE/VCO2 slope between baseline and 4 months
Time frame: 4 Months
Mean change in METS between baseline and 4 months
Time frame: 4 Months
Mean change in health related quality of life assessed by the EuroQoL 5 dimensions - 5 levels (EQ5D-5L) Questionnaire between baseline and 4 months
Time frame: 4 Months
Mean change in vessel volume between patients randomized to exercise and controls
Time frame: 6 Months
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 20 Jan 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation in people with Coronary Microvascular Disease, run by CoreAalst BV at 1 site in Belgium.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 20 Jan 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 Belgium. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in health-related Seattle Angina Questionnaire (SAQ19) between baseline and 4 months (time frame: 4 Months). 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 20 Jan 2026.