Belgian Registry on Coronary Function Testing
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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).
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Coronary Function Test
Diagnostic testCoronary function test may comprise of bolus thermodilution measurements of coronary microvascular function and/or acetylcholine-derived coronary vasoreactivity tests.
Treatment groups
650 Participants
are divided into 1 treatment groupGroup A: BELmicro1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
5 yearsSecondary outcomes
1
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.
Time frame
5 years2
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.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov