Coronary Microvascular Dysfunction Clinical Trial
— BELmicroOfficial title:
A Prospective Multicenter Registry on Coronary Function Tests, Organized by the Belgian Working Group on Coronary Microcirculation/Belgian Microcirculation Registry.
Verified date | October 2023 |
Source | University Hospital, Antwerp |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Recruiting |
Enrollment | 650 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | OLV Aalst | Aalst | |
Belgium | University Hospital Antwerp | Antwerp | |
Belgium | Ziekenhuis aan de Stroom (ZAS) | Antwerp | |
Belgium | AZ Sint-Jan Brugge | Brugge | |
Belgium | AZ Monica | Deurne | Antwerp |
Belgium | Jessa Hasselt | Hasselt | Limburg |
Belgium | AZ Jan Yperman | Ieper | |
Belgium | AZ Groeninge | Kortrijk | |
Belgium | UZ Leuven | Leuven | |
Belgium | CHC Montlégia Liège | Liège | |
Belgium | CHR Citadelle Liège | Liège | |
Belgium | AZ Sint-Maarten | Mechelen | Antwerp |
Belgium | AZ Delta | Roeselare |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 5 years | |
Secondary | 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. | 5 years | |
Secondary | 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. | 5 years |
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