Exercise and Coronary Microvascular Disease

NCT ID: NCT05810051

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2027-10-15

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.

Conditions

Coronary Microvascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Cardiac rehabilitation

Intervention Type: BEHAVIORAL

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.

Optimal medical therapy (OMT)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cardiac rehabilitation

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

CoreAalst BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

OLV Aalst

Aalst, East-Flanders, Belgium

Countries

Belgium

Other Identifiers

CA-021

Identifier Type: -

Identifier Source: org_study_id