Belgian Registry on Coronary Function Testing

Coronary Microvascular Dysfunction Clinical Trial

— BELmicro  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06089031
• Other study ID #: 2021-0522
• Status: Recruiting
• Start date: October 18, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Vasospasm
• Coronary Microvascular Dysfunction
• Coronary Vasospasm

Intervention

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

Locations

Country	Name	City	State
Belgium	OLV Aalst	Aalst
Belgium	University Hospital Antwerp	Antwerp
Belgium	Ziekenhuis aan de Stroom (ZAS)	Antwerp
Belgium	AZ Sint-Jan Brugge	Brugge
Belgium	AZ Monica	Deurne	Antwerp
Belgium	Jessa Hasselt	Hasselt	Limburg
Belgium	AZ Jan Yperman	Ieper
Belgium	AZ Groeninge	Kortrijk
Belgium	UZ Leuven	Leuven
Belgium	CHC Montlégia Liège	Liège
Belgium	CHR Citadelle Liège	Liège
Belgium	AZ Sint-Maarten	Mechelen	Antwerp
Belgium	AZ Delta	Roeselare

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of coronary microvascular dysfunction and/or coronary artery vasospasm	To measure the frequency of coronary microvascular dysfunciton coronary artery and vasomotor disorders among patients undergoing coronary function tests.	5 years
Secondary	Describe predictors for coronary microvascular dysfunction and/or coronary artery vasospasm	To find predictors for coronary microvascular dysfunction and/or coronary artery vasospasm by means of multivariate regression analysis.	5 years
Secondary	Describe 1- year and 3-year MACE among the different endotypes of coronary microvascular dysfunction with/whithout coronary artery spasm.	To describe the difference in 1-year and 3-year MACE between the different endotypes of coronary microvascular dysfunction obtained.	5 years