Clinical trial NCT05810051: Exercise and Coronary Microvascular Disease
Official title: Effects of a Cardiac Rehabilitation Program on Health-related Quality of Life in Patients With Coronary Microvascular Disease.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Microvascular Disease
Keywords: Exercise training
Lead sponsor: CoreAalst BV
Sponsor class: INDUSTRY
Collaborators: name: Abbott Medical Devices
First posted: 2023-04-12
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean change in health-related Seattle Angina Questionnaire (SAQ19) between baseline and 4 months
timeFrame: 4 Months
Secondary outcomes:
measure: Mean change in Seattle Angina Questionnaire (SAQ19)frequency score between baseline and 4 months
timeFrame: 4 Months
measure: Mean change in VO2 peak between baseline and 4 months
timeFrame: 4 Months
measure: Mean change in VE/VCO2 slope between baseline and 4 months
timeFrame: 4 Months
measure: Mean change in METS between baseline and 4 months
timeFrame: 4 Months
measure: Mean change in health related quality of life assessed by the EuroQoL 5 dimensions - 5 levels (EQ5D-5L) Questionnaire between baseline and 4 months
timeFrame: 4 Months
measure: Mean change in vessel volume between patients randomized to exercise and controls
timeFrame: 6 Months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Aalst
state: East-Flanders
Study officials:
References: