Clinical trial NCT06089031: Belgian Registry on Coronary Function Testing
Official title: A Prospective Multicenter Registry on Coronary Function Tests, Organized by the Belgian Working Group on Coronary Microcirculation/Belgian Microcirculation Registry.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Microvascular Dysfunction
Coronary Artery Vasospasm
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Current registry includes each patient in which coronary function tests are performed. The indication for coronary function tests is left to the descretion of the operator. The study population will be broader than the classic use of coronary function tests for angina and non-obstructive coronary arteries (ANOCA).

Brief 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 criteria: 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 outcomes:
measure: Frequency of coronary microvascular dysfunction and/or coronary artery vasospasm
timeFrame: 5 years
Secondary outcomes:
measure: Describe predictors for coronary microvascular dysfunction and/or coronary artery vasospasm
timeFrame: 5 years
measure: Describe 1- year and 3-year MACE among the different endotypes of coronary microvascular dysfunction with/whithout coronary artery spasm.
timeFrame: 5 years
Other outcomes:
Locations:
city: Deurne
country: Belgium
facility: AZ Monica
state: Antwerp
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten
state: Antwerp
city: Hasselt
country: Belgium
facility: Jessa Hasselt
state: Limburg
city: Aalst
country: Belgium
facility: OLV Aalst
city: Antwerp
country: Belgium
facility: Ziekenhuis aan de Stroom (ZAS)
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge
city: Ieper
country: Belgium
facility: AZ Jan Yperman
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHC Montlégia Liège
city: Liège
country: Belgium
facility: CHR Citadelle Liège
city: Roeselare
country: Belgium
facility: AZ Delta
Study officials:
References: