Mechanisms Behind Microvascular Dysfunction in INOCA

ConditionsCoronary Microvascular Dysfunction Ischaemia With Non Obstructed Coronary Arteries

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age50+

SponsorBispebjerg Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

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 population

Ischemia with no obstruction of coronary arteries (INOCA) is estimated to affect \>150.000 Danes and the majority are females. These patients have a shorter life expectancy than age matched controls and a higher incidence of major cardiovascular events (1,2). INOCA is caused by microvascular dysfunction. When there is dysfunction in the microvascu-lature, the blood flow within the coronary vessels fails to increase adequately to meet the de-mand, resulting in ischemia and pain (angina).

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

[15O]H2O-PET Imaging
Diagnostic test
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Ischemia and no obstructive coronary arteries1 intervention

Group B: Control1 intervention

Trial outcomes

Primary outcomes

Vascular function in response to acetylcholine stress

Vascular conductance measured by ultrasound doppler during infusion of acetylcholine

Time frame

Baseline only

Secondary outcomes

Vascular function in response to acetylcholine adenosine stress

Vascular conductance measured by ultrasound doppler during infusion of Adenosine

Time frame

Baseline only

Myocardial Blood flow reserve

Determined by the clinical assessment of \[15O\]H2O-PET

Time frame

Baseline only

Skeletal Muscle Microvascular Function

Evaluated by brachial artery ultrasound Doppler in response to exercise stress to measure blood flow responsiveness in skeletal muscles.

Time frame

Baseline only

Changes in isolated small artery reactivity assessed with myography

Analyzed using myograph to study the tone of smooth muscle cells

Time frame

Baseline only

Other outcomes

Tone of smooth muscle cells

Changes in isolated small artery reactivity assessed with myography

Time frame

Baseline only

Proteomic and transcriptomic analyses

Changes in gene and protein expressions patterns in small arteries

Time frame

Baseline only

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bispebjerg Hospital

Lead sponsor

University of Copenhagen

Collaborator

Source ClinicalTrials.gov

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