NCT05810051

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Jul 2023Oct 2027

First Submitted

Initial submission to the registry

March 30, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

July 31, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2027

Expected
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

March 30, 2023

Last Update Submit

January 16, 2026

Conditions

Coronary Microvascular Disease

Keywords

Exercise training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Mean change in Seattle Angina Questionnaire (SAQ19)frequency score between baseline and 4 months

    4 Months

  • Mean change in VO2 peak between baseline and 4 months

    4 Months

  • Mean change in VE/VCO2 slope between baseline and 4 months

    4 Months

  • Mean change in METS between baseline and 4 months

    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

    4 Months

  • +1 more secondary outcomes

Study Arms (2)

Optimal medical therapy (OMT) plus a program of cardiac rehabilitation (CR)

EXPERIMENTAL

The intervention group will receive cardiac rehabilitation in addition to lifestyle changes and pharmacological treatment.

Behavioral: Cardiac rehabilitation

Optimal medical therapy (OMT)

NO INTERVENTION

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.

Interventions

Cardiac rehabilitationBEHAVIORAL

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.

Optimal medical therapy (OMT) plus a program of cardiac rehabilitation (CR)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non obstructive CAD (diameter stenosis \<50% visual or FFR \> 0.80)
  • Angina at presentation
  • Evidence of microvascular dysfunction (IMR ≥ 25)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OLV Aalst

Aalst, East-Flanders, 9300, Belgium

Location

MeSH Terms

Conditions

Microvascular Angina

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 12, 2023

Study Start

July 31, 2023

Primary Completion

April 15, 2026

Study Completion (Estimated)

October 15, 2027

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

BE(1)