Impact of Exercise Training on Ischemia With Non-Obstructive Coronary Arteries (INOCA): The ExINOCA Study
NCT Number: NCT06529848
Acronym: ExINOCA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Microvascular Disease|CMD
Interventions: OTHER: Exercise training
Sponsor: Bispebjerg Hospital
Collaborators: University of Copenhagen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2028-05-15
Locations: Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57, Frederiksberg, Denmark, 2000, Copenhagen, 2400, Denmark|Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57, Frederiksberg, 2000, Denmark

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.

Primary Outcome Measures: Change in Myocardial Blood Flow Reserve (MBFR), Change in MBFR assessed by \[15O\]H2O-PET-scan, From baseline and after 3 months
Secondary Outcome Measures: Change in symptom burden assessed by Seattle Angina Questionnaire, Seattle angina questionnaire/selfreported (scale range 0-100, 0=poor and 100=excellent health status), From baseline and after 3 months|Change in exercise capacity, Oxygen uptake during exhaustive exercise, From baseline and after 3 months|Change in global rest perfusion in patients with angina symptoms and CMD, Change in Myocardial Blood Flow assessed by \[15O\]H2O-PET-scan, From baseline and after 3 months|Change in global stress perfusion in patients with angina symptoms and CMD, Change in hyperemic Myocardial Blood Flow assessed by \[15O\]H2O-PET-scan, From baseline and after 3 months
Other Outcome Measures: Vascular Function Adaptations, Changes in Arterial compliance (C = ΔV/ ΔP) calculated from intraarterial pressure ΔP and arterial diameter (ΔD) measured by ultrasound Doppler, From baseline and after 3 months|Changes in skin microvascular function, Hand microcirculatory blood flow assessed by Laser Speckle Contrast Imaging, From baseline and after 3 months|Change in plasma levels of markers related to vascular function, Plasma levels of markers related to vascular function assessed by Mesoscale/ELISA, From baseline and after 3 months|Changes in Arterial Blood Pressure, Assessed by automated blood pressure at rest, From baseline and after 3 months|Change in plasma Lipids, Conducted through clinical chemical analysis to measure levels of HDL, and triglycerides in the blood, providing insights into lipid profiles., From baseline and after 3 months|Changes in Plasma Levels of Inflammatory Markers, Measured using Mesoscale/ELISA/O-Link platforms to evaluate the presence and levels of inflammatory markers, indicating systemic inflammation., From baseline and after 3 months|Proteomic and transcriptomic analyses, Changes in gene and protein expressions patterns in small arteries, From baseline and after 3 months