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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06089031
Other study ID # 2021-0522
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 18, 2021
Est. completion date December 31, 2026

Study information

Verified date October 2023
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

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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