BELmicro: Belgian Registry on Coronary Function Testing
Study Details
Study Description
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:
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how frequent are coronary function tests performed
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what is the indication for coronary function tests
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what is the frequency of coronary microvascular dysfunction
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| BELmicro No intervention foreseen. |
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.
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Outcome Measures
Primary Outcome Measures
- Frequency of coronary microvascular dysfunction and/or coronary artery vasospasm [5 years]
To measure the frequency of coronary microvascular dysfunciton coronary artery and vasomotor disorders among patients undergoing coronary function tests.
Secondary Outcome Measures
- Describe predictors for coronary microvascular dysfunction and/or coronary artery vasospasm [5 years]
To 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 years]
To describe the difference in 1-year and 3-year MACE between the different endotypes of coronary microvascular dysfunction obtained.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient scheduled for coronary function test, comprising of intracoronary bolus thermodilution measurements of microvascular function, and/or intracoronary vasoreactivity tests with acetylcholine.
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Subject understands the study requirements and provides written informed consent.
Exclusion Criteria:
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Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.
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Subject intends to participate in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.
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Documented or suspected pregnancy.
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Inability to provide written informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AZ Monica | Deurne | Antwerp | Belgium | 2100 |
| 2 | AZ Sint-Maarten | Mechelen | Antwerp | Belgium | 2800 |
| 3 | Jessa Hasselt | Hasselt | Limburg | Belgium | 3500 |
| 4 | OLV Aalst | Aalst | Belgium | 9300 | |
| 5 | Ziekenhuis aan de Stroom (ZAS) | Antwerp | Belgium | 2020 | |
| 6 | University Hospital Antwerp | Antwerp | Belgium | 2650 | |
| 7 | AZ Sint-Jan Brugge | Brugge | Belgium | 8000 | |
| 8 | AZ Jan Yperman | Ieper | Belgium | 8900 | |
| 9 | AZ Groeninge | Kortrijk | Belgium | 8500 | |
| 10 | UZ Leuven | Leuven | Belgium | 3000 | |
| 11 | CHC Montlégia Liège | Liège | Belgium | 4000 | |
| 12 | CHR Citadelle Liège | Liège | Belgium | ||
| 13 | AZ Delta | Roeselare | Belgium | 8800 |
Sponsors and Collaborators
- University Hospital, Antwerp
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-0522