Belgian Registry on Coronary Function Testing (BELmicro)

October 12, 2023 updated by: University Hospital, Antwerp

A Prospective Multicenter Registry on Coronary Function Tests, Organized by the Belgian Working Group on Coronary Microcirculation/Belgian Microcirculation 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
      • Antwerp, Belgium, 2650
        • Recruiting
        • University Hospital Antwerp
        • Contact:
        • Principal Investigator:
          • Vincent FM Segers, MD, PhD
      • Antwerp, Belgium, 2020
        • Recruiting
        • Ziekenhuis Aan de Stroom (ZAS)
        • Contact:
        • Sub-Investigator:
          • Alice Benedetti, MD
      • Brugge, Belgium, 8000
      • Ieper, Belgium, 8900
      • Kortrijk, Belgium, 8500
      • Leuven, Belgium, 3000
      • Liège, Belgium, 4000
        • Recruiting
        • CHC Montlégia Liège
        • Contact:
      • Liège, Belgium
      • Roeselare, Belgium, 8800
    • Antwerp
      • Deurne, Antwerp, Belgium, 2100
      • Mechelen, Antwerp, Belgium, 2800
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Recruiting
        • JESSA Hasselt
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Current registry includes each patient in which coronary function tests are performed. The indication for coronary function tests is left to the descretion of the operator. The study population will be broader than the classic use of coronary function tests for angina and non-obstructive coronary arteries (ANOCA).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of coronary microvascular dysfunction and/or coronary artery vasospasm
Time Frame: 5 years
To measure the frequency of coronary microvascular dysfunciton coronary artery and vasomotor disorders among patients undergoing coronary function tests.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe predictors for coronary microvascular dysfunction and/or coronary artery vasospasm
Time Frame: 5 years
To find predictors for coronary microvascular dysfunction and/or coronary artery vasospasm by means of multivariate regression analysis.
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
To describe the difference in 1-year and 3-year MACE between the different endotypes of coronary microvascular dysfunction obtained.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

October 12, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0522

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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