Belgian Registry on Coronary Function Testing

The goal of this prospective, multicenter registy is to describe the 'real-world' use of coronary function tests, which may consist of bolus thermodilution measurements of coronary microvascular function and/or invasive vasoreactivity tests with acetylcholine, in the current Belgian routine practice. The main questions it aims to answer are:

* how frequent are coronary function tests performed * what is the indication for coronary function tests * what is the frequency of coronary microvascular dysfunction * what is the frequency of coronary artery vasospasm

From each participant, data will be collected from their medical files concerning cardiovascular risk factors, relevant past medical history, non-invasive tests, procedural data, and follow-up data from routine in-patient visits. Their are no specific study visits. Optionally, patients will be asked to fill in questionnaires about anginal symptoms and quality of life.

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Key information

Conditions

Coronary Microvascular Dysfunction Cardiovascular Diseases Coronary Artery Vasospasm Coronary Disease Coronary Vasospasm Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Monica, Deurne, Antwerp, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient scheduled for coronary function test, comprising of intracoronary bolus thermodilution measurements of microvascular function, and/or intracoronary vasoreactivity tests with acetylcholine.
Subject understands the study requirements and provides written informed consent.

Exclusion criteria

Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.
Subject intends to participate in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.
Documented or suspected pregnancy.
Inability to provide written informed consent.

Treatment and study plan

Coronary Function Test

Diagnostic Test

Coronary function test may comprise of bolus thermodilution measurements of coronary microvascular function and/or acetylcholine-derived coronary vasoreactivity tests.

Primary outcomes

Frequency of coronary microvascular dysfunction and/or coronary artery vasospasm

Time frame: 5 years

To measure the frequency of coronary microvascular dysfunciton coronary artery and vasomotor disorders among patients undergoing coronary function tests.

Secondary outcomes

Describe predictors for coronary microvascular dysfunction and/or coronary artery vasospasm

Time frame: 5 years

To find predictors for coronary microvascular dysfunction and/or coronary artery vasospasm by means of multivariate regression analysis.
Describe 1- year and 3-year MACE among the different endotypes of coronary microvascular dysfunction with/whithout coronary artery spasm.

Time frame: 5 years

To describe the difference in 1-year and 3-year MACE between the different endotypes of coronary microvascular dysfunction obtained.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

A Prospective Multicenter Registry on Coronary Function Tests, Organized by the Belgian Working Group on Coronary Microcirculation/Belgian Microcirculation Registry.

Acronym: BELmicro

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2026
First posted: Oct 18, 2023
Registry last updated: Oct 18, 2023

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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