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NCT06529848 | NOT YET RECRUITING | Coronary Microvascular Disease

Impact of Exercise Training on Ischemia With Non-Obstructive Coronary Arteries (INOCA): The ExINOCA Study
Sponsor:

Bispebjerg Hospital

Information provided by (Responsible Party):

Eva Prescott

Brief Summary:

The purpose of the study is to identify causes of chest pain in patients experiencing chest pain with no signs of narrowing of the coronary arteries of the heart, and to investigate whether physical exercise can improve coronary microvascular function. Hypotheses: The first hypothesis is that in INOCA, with reduced function of microvasculature of the heart, this reduced function also occurs in other organs of the body. The second hypothesis is that regular physical activity (aerobic exercise training) can improve coronary microvascular function, reduce symptoms, and that there is a parallel improvement in vascular function in other organs of the body.

Condition or disease

Coronary Microvascular Disease

CMD

Intervention/treatment

Exercise training

Phase

NA

Detailed Description:

A significant number of patients suspected of chronic coronary syndrome do not have coronary artery obstruction and in a large proportion of these, their symptoms are attributed to coronary microvascular dysfunction (CMD), a condition known as ischemia with no obstructive coronary artery disease (INOCA). Despite a considerable patient population affected by INOCA, the specific mechanisms underlying CMD are not fully understood, often resulting in a lack of targeted treatment. There is evidence to suggest that exercise capacity is linked to coronary microvascular function, positing that exercise training could potentially reverse microvascular dysfunction and address its mechanistic origins, a hypothesis yet to be explored. This study aims to identify mechanisms underlying CMD in angina and to assess whether exercise training can improve the condition. The current study is a randomized controlled trial testing the effect of exercise training in patients with CMD. 100 patients will be randomized 1:1 to exercise training or control. The primary outcome is coronary microvascular function, secondary outcomes include symptoms and microvascular function in cutaneous tissue, skeletal muscle, and adipose tissue.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Ischemia With No Obstruction of Coronary Arteries: Underlying Mechanisms and the Impact of Exercise Training (EXINOCA)
Actual Study Start Date : 2024-10-01
Estimated Primary Completion Date : 2027-10-30
Estimated Study Completion Date : 2028-05-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Coronary microvascular dysfunction, defined as myocardial bloodflow reserve (MBFR) \< 2.5 or hyperemic myocar-dial blood flow (hMBF)\<2.3 ml/g/min using \[15O\]H2O-PET
  • * No obstructive coronary artery disease
Exclusion Criteria
  • * Females of childbearing potential (defined as a premeno-pausal female capable of becoming pregnant). The female patient must either be postmenopausal, defined as amen-orrhea for at least 1 year, or surgically sterile
  • * Heart failure, defined as left ventricular ejection fraction of less than 40%
  • * Uncontrolled hypertension defined as blood pressure above target 140/90 for all
  • * Co-morbidity resulting in \<1 year expected survival
  • * Considered by the investigator, for any reason, to be an un-suitable candidate for the study.
  • * Unable or unwilling to exercise, e.g. due to arthritis or in-jury\*
  • * Already are regularly physically active and/or have a maxi-mal oxygen uptake \>45 ml/kg/min
Impact of Exercise Training on Ischemia With Non-Obstructive Coronary Arteries (INOCA): The ExINOCA Study

Location Details

NCT06529848

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How to Participate

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Locations

Not yet recruiting

Denmark,

Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57, Frederiksberg, Denmark, 2000

Copenhagen, Denmark, 2400

Not yet recruiting

Denmark,

Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57

Frederiksberg, Denmark, 2000