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

ConditionsCoronary Microvascular Disease CMD

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50+

SponsorBispebjerg Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Exercise training
Other intervention
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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: ExerciseActive comparator 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes