Belgian Registry on Coronary Function Testing

Recruiting

• Conditions: Coronary Microvascular Dysfunction; Coronary Artery Vasospasm
• Interventions: Diagnostic Test: Coronary Function Test

• Registration Number: NCT06089031
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-18
• Status Verified: 2023-10
• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-12
• Last Update Submitted: 2023-10-12
• Study First Posted: 2023-10-18
• Last Update Posted: 2023-10-18
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BELmicro	Coronary Function Test	No intervention foreseen.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Describe predictors for coronary microvascular dysfunction and/or coronary artery vasospasm	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.	5 years	To describe the difference in 1-year and 3-year MACE between the different endotypes of coronary microvascular dysfunction obtained.

Trial Locations

Locations (13)

AZ Monica; 🇧🇪 Deurne, Antwerp, Belgium

OLV Aalst; 🇧🇪 Aalst, Belgium

CHC Montlégia Liège; 🇧🇪 Liège, Belgium

AZ Sint-Maarten; 🇧🇪 Mechelen, Antwerp, Belgium

Ziekenhuis aan de Stroom (ZAS); 🇧🇪 Antwerp, Belgium

University Hospital Antwerp; 🇧🇪 Antwerp, Belgium

AZ Sint-Jan Brugge; 🇧🇪 Brugge, Belgium

CHR Citadelle Liège; 🇧🇪 Liège, Belgium

Jessa Hasselt; 🇧🇪 Hasselt, Limburg, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium

AZ Jan Yperman; 🇧🇪 Ieper, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium