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Recruiting Observational

Belgian Registry on Coronary Function Testing

NCT06089031 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2021-10-18
Last updated
2023-10-18

Condition(s) studied

Coronary Microvascular DysfunctionCoronary Artery Vasospasm

Investigational drug(s) / intervention(s)

Coronary Function Test

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Frequency of coronary microvascular dysfunction and/or coronary artery vasospasm — 5 years
    To measure the frequency of coronary microvascular dysfunciton coronary artery and vasomotor disorders among patients undergoing coronary function tests.

Trial sites (13)

FacilityCityRegionStatus
AZ Monica Deurne Antwerp Recruiting
AZ Sint-Maarten Mechelen Antwerp Recruiting
Jessa Hasselt Hasselt Limburg Recruiting
OLV Aalst Aalst Belgium Recruiting
Ziekenhuis aan de Stroom (ZAS) Antwerp Belgium Recruiting
University Hospital Antwerp Antwerp Belgium Recruiting
AZ Sint-Jan Brugge Bruges Belgium Recruiting
AZ Jan Yperman Ieper Belgium Recruiting
AZ Groeninge Kortrijk Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
CHC Montlégia Liège Liège Belgium Recruiting
CHR Citadelle Liège Liège Belgium Recruiting
AZ Delta Roeselare Belgium Recruiting
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 NCT06089031 on ClinicalTrials.gov ↗ ← All trials in Belgium