Belgian Registry on Coronary Function Testing (BELmicro)

Antwerp University Hospital (UZA)

Status: Enrolling

Conditions: Coronary Microvascular Dysfunction; Coronary Artery Vasospasm

Treatments: Diagnostic Test: Coronary Function Test

Study type: Observational

Funder types: Other

Identifiers

NCT06089031

2021-0522

Details and patient eligibility

About

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.

Enrollment: 650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

650 participants in 1 patient group

BELmicro

Description:

No intervention foreseen.

Treatment:

Diagnostic Test: Coronary Function Test