Menu
Not yet recruiting NCT06529861

Mechanisms Behind Microvascular Dysfunction in INOCA

— Observational Coronary Microvascular Dysfunction Ischaemia With Non Obstructed Coronary Arteries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [15O]H2O-PET Imaging.
Who it may be relevant to
Registry conditions: Coronary Microvascular Dysfunction, Ischaemia With Non Obstructed Coronary Arteries. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Identification of Mechanisms Behind Microvascular Dysfunction in Ischemia With No Obstructive Coronary Artery Disease

Overview

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.

Detailed description

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.

Interventions

  • Diagnostic test [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.

Primary outcome measures

  • Vascular function in response to acetylcholine stress [Time frame: Baseline only]
Secondary outcome measures (11)
  • Vascular function in response to acetylcholine adenosine stress [Time frame: Baseline only]
  • Myocardial Blood flow reserve [Time frame: Baseline only]
  • Skeletal Muscle Microvascular Function [Time frame: Baseline only]
  • Changes in isolated small artery reactivity assessed with myography [Time frame: Baseline only]
  • Arterial Compliance [Time frame: Baseline only]
  • Plasma Lipids [Time frame: Baseline only]
  • Plasma HbA1c [Time frame: Baseline only]
  • Plasma Levels of Markers Related to Vascular Function [Time frame: Baseline only]
  • Plasma Levels of Inflammatory Markers [Time frame: Baseline only]
  • Arterial Blood Pressure [Time frame: Baseline only]
  • Cardiac Function [Time frame: Baseline only]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57, Frederik — Copenhagen

Identifiers

NCT: NCT06529861 · ExINOCA - Part I

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗