Impact of Exercise Training on Ischemia With Non-Obstructive Coronary Arteries (INOCA): The ExINOCA Study
Ischemia With No Obstruction of Coronary Arteries: Underlying Mechanisms and the Impact of Exercise Training (EXINOCA)
Bispebjerg Hospital
100 participants
Nov 1, 2024
INTERVENTIONAL
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.
Eligibility
Inclusion Criteria2
- 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 Criteria7
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The training sessions are consist of cycling and as follows: a 10 min warm-up at a light intensity, 20-35 min of cycling exercise in intervals at varying intensities from light (\~60% of max heart rate) to more intensive (80-90% of max heart rate) and ending with 5 min of warm-down at a light intensity. The training intensity will be progressive during the course of the intervention period. The cycling training sessions are supervised . Home training is allowed up to once a week if participants are able to adhere to the prescribed intensity levels. Training sessions are closely monitored to ensure effectiveness and safety. This includes heart rate monitoring, perceived exertion assessment.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06529848