Exercise and Coronary Microvascular Disease
- Conditions
- Coronary Microvascular Disease
- Interventions
- Behavioral: Cardiac rehabilitation
- Registration Number
- NCT05810051
- Lead Sponsor
- CoreAalst BV
- Brief 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 204
- Non obstructive CAD (diameter stenosis <50% visual or FFR > 0.80)
- Angina at presentation
- Evidence of microvascular dysfunction (IMR ≥ 25)
- Inability to give consent
- Acute coronary syndrome (ACS)
- Severe valve disease
- Permanent AF
- History of coronary artery bypass grafting (CABG)
- Cardiomyopathies
- Intolerance to adenosine
- Hemodynamic instability
- Not able to exercise
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Optimal medical therapy (OMT) plus a program of cardiac rehabilitation (CR) Cardiac rehabilitation The intervention group will receive cardiac rehabilitation in addition to lifestyle changes and pharmacological treatment.
- Primary Outcome Measures
Name Time Method Mean change in health-related Seattle Angina Questionnaire (SAQ19) between baseline and 4 months 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.
- Secondary Outcome Measures
Name Time Method Mean change in VO2 peak between baseline and 4 months 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
Mean change in VE/VCO2 slope between baseline and 4 months 4 Months Mean change in ventilatory efficiency, as assessed by the VE/VCO2 slope derived from spiro-ergometry test, between baseline and 4 months
Mean change in Seattle Angina Questionnaire (SAQ19)frequency score between baseline and 4 months 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.
Mean change in METS between baseline and 4 months 4 Months Mean change in Metabole equivalents (METS) derived from spiro-ergometry test between baseline and 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 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.
Mean change in vessel volume between patients randomized to exercise and controls 6 Months 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).
Trial Locations
- Locations (1)
OLV Aalst
🇧🇪Aalst, East-Flanders, Belgium