Exercise and Coronary Microvascular Disease (ExerciseCMD)

CoreAalst

Status: Enrolling

Conditions: Coronary Microvascular Disease

Treatments: Behavioral: Cardiac rehabilitation

Study type: Interventional

Funder types: Industry

Identifiers

NCT05810051

CA-021

Details and patient eligibility

About

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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non obstructive CAD (diameter stenosis <50% visual or FFR > 0.80)
• Angina at presentation
• Evidence of microvascular dysfunction (IMR ≥ 25)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Optimal medical therapy (OMT) plus a program of cardiac rehabilitation (CR)

Experimental group

Description:

The intervention group will receive cardiac rehabilitation in addition to lifestyle changes and pharmacological treatment.

Treatment:

Behavioral: Cardiac rehabilitation

Optimal medical therapy (OMT)

No Intervention group

Description:

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.