Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57, Frederiksberg, Denmark, 2000
Copenhagen, 2400, Denmark
NCT Number: NCT06529861
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.
Trial opening soon.
Get Notified50 year and older
All sexes
Observational
Copenhagen, 2400, Denmark
A significant number of patients with ischemic heart disease do not exhibit coronary obstruction, leading to their symptoms being attributed to coronary microvascular dysfunction, a condition known as ischemia with no obstructive coronary artery disease (INOCA). Despite a considerable patient population affected by INOCA, the specific mechanisms underlying this microvascular dysfunction are not fully understood, often resulting in a lack of targeted treatment. There is evidence to suggest that exercise capacity is linked to coronary microvascular function, an area yet to be explored.
This study aims to identify mechanisms underlying Coronary microvascular dysfunction (CMD) in angina and to assess whether exercise training can improve the condition. In study part I 30 patients with impaired coronary microvascular function and 30 asymptomatic controls will be studied to identify vascular and related molecular mechanisms underlying INOCA by investigating microvascular function in the heart and in cutaneous tissue, skeletal muscle, and adipose tissue.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
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.
Time frame: Baseline only
Vascular conductance measured by ultrasound doppler during infusion of acetylcholine
Time frame: Baseline only
Vascular conductance measured by ultrasound doppler during infusion of Adenosine
Time frame: Baseline only
Determined by the clinical assessment of [15O]H2O-PET
Time frame: Baseline only
Evaluated by brachial artery ultrasound Doppler in response to exercise stress to measure blood flow responsiveness in skeletal muscles.
Time frame: Baseline only
Analyzed using myograph to study the tone of smooth muscle cells
Time frame: Baseline only
Determined by calculations made from intra-arterial pressure and arterial diameter measurements obtained via ultrasound Doppler to assess arterial compliance.
Time frame: Baseline only
Conducted through clinical chemical analysis to measure levels of HDL, and triglycerides in the blood, providing insights into lipid profiles.
Time frame: Baseline only
Conducted through clinical chemical analysis to measure levels of HbA1c in the blood, providing insights into glucose metabolism.
Time frame: Baseline only
Assessed using Mesoscale/ELISA to quantify biomarkers associated with vascular function
Time frame: Baseline only
Measured using Mesoscale/ELISA/O-Link platforms to evaluate the presence and levels of inflammatory markers
Time frame: Baseline only
Monitored with automated blood pressure measurements at rest and during exercise to assess overall cardiovascular health and response to physical activity.
Time frame: Baseline only
Changes in stroke volume using echocardiography during rest and exercise stress
Time frame: Baseline only
Changes in isolated small artery reactivity assessed with myography
Time frame: Baseline only
Changes in gene and protein expressions patterns in small arteries
Contact information is provided by the study sponsor or research team.
Eva Prescott, MD, DMSc
CONTACT
Mads Fischer, Ph.D.
CONTACT
Bispebjerg Hospital
Other
Identification of Mechanisms Behind Microvascular Dysfunction in Ischemia With No Obstructive Coronary Artery Disease
Acronym: ExINOCA-P1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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