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Starting soon Observational

Mechanisms Behind Microvascular Dysfunction in INOCA

NCT06529861 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2024-10-01
Last updated
2024-07-31

Condition(s) studied

Coronary Microvascular DysfunctionIschaemia With Non Obstructed Coronary Arteries

Investigational drug(s) / intervention(s)

[15O]H2O-PET Imaging

[15O]H2O-PET Imaging: This imaging technique will be used to measure myocardial blood flow (MBF) and myocardial blood flow reserve (MBFR) in patients. The PET-CT scan involves the use of the radioactive tracer \[15O\]H2O to visualize blood flow in the heart, providing crucial data on coronary microvascular function.

Study summary

The purpose of the study is to identify the causes of chest pain in patients experiencing chest pain with no signs of narrowing in the coronary arteries of the heart.

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: Only for angina patients: Have CMD, defined as myocardial bloodflow re-serve (MBFR) \< 2.5 or hyperemic myocardial blood flow (hMBF) \< 2.3ml/g/min 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 unsuitable candidate for the study. * Unable or unwilling to exercise, e.g. due to arthritis or injury\* * Already are regularly physically active and/or have a maximal oxygen uptake \>45 ml/kg/min * The subject has a known allergy to either: norepinephrine, adenosine, ketorolac, and or ascorbic acid (vitamin C).

Primary outcome measure(s)

  • Vascular function in response to acetylcholine stress — Baseline only
    Vascular conductance measured by ultrasound doppler during infusion of acetylcholine

Trial sites (1)

FacilityCityRegionStatus
Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57, Frederiksberg, Denmark, 2000 Copenhagen Denmark
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06529861 on ClinicalTrials.gov ↗ ← All trials in Denmark