Belgian Registry on Coronary Function Testing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coronary Function Test.
- Who it may be relevant to
- Registry conditions: Coronary Microvascular Dysfunction, Coronary Artery Vasospasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Multicenter Registry on Coronary Function Tests, Organized by the Belgian Working Group on Coronary Microcirculation/Belgian Microcirculation Registry.
Overview
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 test Coronary Function Test
Coronary function test may comprise of bolus thermodilution measurements of coronary microvascular function and/or acetylcholine-derived coronary vasoreactivity tests.
Primary outcome measures
- Frequency of coronary microvascular dysfunction and/or coronary artery vasospasm [Time frame: 5 years]
Secondary outcome measures (2)
- Describe predictors for coronary microvascular dysfunction and/or coronary artery vasospasm [Time frame: 5 years]
- Describe 1- year and 3-year MACE among the different endotypes of coronary microvascular dysfunction with/whithout coronary artery spasm. [Time frame: 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Belgium · 13 centers
- AZ Monica — Deurne
- AZ Sint-Maarten — Mechelen
- Jessa Hasselt — Hasselt
- OLV Aalst — Aalst
- Ziekenhuis aan de Stroom (ZAS) — Antwerp
- University Hospital Antwerp — Antwerp
- AZ Sint-Jan Brugge — Bruges
- AZ Jan Yperman — Ieper
- … and 5 more centers
Identifiers
NCT: NCT06089031 · 2021-0522