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Belgian Registry on Coronary Function Testing

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06089031
Acronym
BELmicro
Enrollment
650
Registered
2023-10-18
Start date
2021-10-18
Completion date
2026-12-31
Last updated
2023-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Microvascular Dysfunction, Coronary Artery Vasospasm

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.

Interventions

DIAGNOSTIC_TESTCoronary Function Test

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

Sponsors

University Hospital, Antwerp
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of coronary microvascular dysfunction and/or coronary artery vasospasm5 yearsTo measure the frequency of coronary microvascular dysfunciton coronary artery and vasomotor disorders among patients undergoing coronary function tests.

Secondary

MeasureTime frameDescription
Describe predictors for coronary microvascular dysfunction and/or coronary artery vasospasm5 yearsTo 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 yearsTo describe the difference in 1-year and 3-year MACE between the different endotypes of coronary microvascular dysfunction obtained.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026