Belgian Registry on Coronary Function Testing

Study Overview
=================
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.

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

Conditions
-----------------
Coronary Microvascular Dysfunction, Coronary Artery Vasospasm

Intervention / Treatment
-----------------
* Diagnostic Test: Coronary Function Test


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BELmicro<br>No intervention foreseen. | Diagnostic Test: Coronary Function Test<br>* Coronary function test may comprise of bolus thermodilution measurements of coronary microvascular function and/or acetylcholine-derived coronary vasoreactivity tests.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |