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Exercise and Coronary Microvascular Disease

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

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

Study details

Coronary Microvascular Disease

NCT05810051

CoreAalst BV

26 January 2024

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