Exercise and Coronary Microvascular Disease

Coronary Microvascular Disease Clinical Trial

— ExerciseCMD  

Official title:

Effects of a Cardiac Rehabilitation Program on Health-related Quality of Life in Patients With Coronary Microvascular Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05810051
• Other study ID #: CA-021
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: October 2025

Study information

• Verified date: November 2023
• Source: CoreAalst BV
• Contact: Sofie Pardaens, PhD
• Phone: 0032 53 72 42 30
• Email: sofiepardaens[@]coreaalst.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: October 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Coronary Microvascular Disease
• Microvascular Angina

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Belgium	OLV Aalst	Aalst	East-Flanders

Sponsors (2)

Lead Sponsor	Collaborator
CoreAalst BV	Abbott Medical Devices

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in health-related Seattle Angina Questionnaire (SAQ19) between baseline and 4 months	Mean change in health-related quality of life questionnaire as assessed by the Seattle Angina Questionnaire 19, between baseline and 4 months (SAQ-19 Summary Score) with a maximum score of 100 representing a good quality of life.	4 Months
Secondary	Mean change in Seattle Angina Questionnaire (SAQ19)frequency score between baseline and 4 months	Mean change in the Seattle Angina Questionnaire frequency score between baseline and 4 months with a maximum score of 100 representing no angina symptoms.	4 Months
Secondary	Mean change in VO2 peak between baseline and 4 months	Mean change in exercise capacity, as assessed by the peak oxygen consumption (VO2 peak) derived from spiro-ergometry test between baseline and 4 months	4 Months
Secondary	Mean change in VE/VCO2 slope between baseline and 4 months	Mean change in ventilatory efficiency, as assessed by the VE/VCO2 slope derived from spiro-ergometry test, between baseline and 4 months	4 Months
Secondary	Mean change in METS between baseline and 4 months	Mean change in Metabole equivalents (METS) derived from spiro-ergometry test between baseline and 4 months	4 Months
Secondary	Mean change in health related quality of life assessed by the EuroQoL 5 dimensions - 5 levels (EQ5D-5L) Questionnaire between baseline and 4 months	Mean change in health related quality of life as assessed by the EuroQoL 5 dimensions - 5 levels EQ5D-5L Index score between baseline and 4 months with a score of 1 representing a perfect health condition.	4 Months
Secondary	Mean change in vessel volume between patients randomized to exercise and controls	Mean change in vessel volume as assessed by coronary CT angiography between patients randomized to exercise and controls (only for patients with baseline coronary CT angiography).	6 Months