Exercise and Coronary Microvascular Disease (ExerciseCMD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Microvascular Disease
• Intervention / Treatment: Behavioral: Cardiac rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sofie Pardaens, PhD; Phone Number: 0032 53 72 42 30; Email: sofiepardaens@coreaalst.com

Study Locations

• Belgium
  • East-Flanders
    • Aalst, East-Flanders, Belgium, 9300
      • Recruiting
      • OLV Aalst
      • Contact: Sofie Pardaens, PhD; Phone Number: 0032 53 72 42 30; Email: sofiepardaens@coreaalst.com
      • Principal Investigator: Sofie Brouwers, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: CoreAalst BV
• Collaborators: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Exercise training
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Microvascular Angina
• Other Study ID Numbers: CA-021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No