Last reviewed · How we verify

Exercise and Coronary Microvascular Disease (ExerciseCMD)

NCT05810051 NA ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsorCoreAalst BV
PhaseNA
StatusACTIVE_NOT_RECRUITING
Enrolment204
Start dateMon Jul 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionFri Oct 15 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

Belgium