Exercise and Coronary Microvascular Disease

Last updated: January 22, 2025
Sponsor: CoreAalst BV
Overall Status: Active - Recruiting

Phase

N/A

Condition

Angina

Treatment

Cardiac rehabilitation

Clinical Study ID

NCT05810051
CA-021
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Non obstructive CAD (diameter stenosis <50% visual or FFR > 0.80)

  • Angina at presentation

  • Evidence of microvascular dysfunction (IMR ≥ 25)

Exclusion

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

Study Design

Total Participants: 204
Treatment Group(s): 1
Primary Treatment: Cardiac rehabilitation
Phase:
Study Start date:
July 31, 2023
Estimated Completion Date:
October 31, 2027

Connect with a study center

  • OLV Aalst

    Aalst, East-Flanders 9300
    Belgium

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.