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Clinical Trials/NCT06089031
NCT06089031
Recruiting
Not Applicable

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

University Hospital, Antwerp13 sites in 1 country650 target enrollmentOctober 18, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Microvascular Dysfunction
Sponsor
University Hospital, Antwerp
Enrollment
650
Locations
13
Primary Endpoint
Frequency of coronary microvascular dysfunction and/or coronary artery vasospasm
Status
Recruiting
Last Updated
2 years ago

Overview

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:

  • 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.

Registry
clinicaltrials.gov
Start Date
October 18, 2021
End Date
December 31, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Describe predictors for coronary microvascular dysfunction and/or coronary artery vasospasm(5 years)
  • Describe 1- year and 3-year MACE among the different endotypes of coronary microvascular dysfunction with/whithout coronary artery spasm.(5 years)

Study Sites (13)

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