NCT06089031

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Oct 2021Dec 2026

Study Start

First participant enrolled

October 18, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

4.2 years

First QC Date

October 12, 2023

Last Update Submit

October 12, 2023

Conditions

Coronary Microvascular DysfunctionCoronary Artery Vasospasm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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 Arms (1)

BELmicro

No intervention foreseen.

Diagnostic Test: Coronary Function Test

Interventions

Coronary Function TestDIAGNOSTIC_TEST

Coronary function test may comprise of bolus thermodilution measurements of coronary microvascular function and/or acetylcholine-derived coronary vasoreactivity tests.

BELmicro

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

AZ Monica

Deurne, Antwerp, 2100, Belgium

RECRUITING

AZ Sint-Maarten

Mechelen, Antwerp, 2800, Belgium

RECRUITING

Jessa Hasselt

Hasselt, Limburg, 3500, Belgium

RECRUITING

OLV Aalst

Aalst, 9300, Belgium

RECRUITING

Ziekenhuis aan de Stroom (ZAS)

Antwerp, 2020, Belgium

RECRUITING

University Hospital Antwerp

Antwerp, 2650, Belgium

RECRUITING

AZ Sint-Jan Brugge

Bruges, 8000, Belgium

RECRUITING

AZ Jan Yperman

Ieper, 8900, Belgium

RECRUITING

AZ Groeninge

Kortrijk, 8500, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

CHC Montlégia Liège

Liège, 4000, Belgium

RECRUITING

CHR Citadelle Liège

Liège, Belgium

RECRUITING

AZ Delta

Roeselare, 8800, Belgium

RECRUITING

MeSH Terms

Conditions

Coronary Vasospasm

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 18, 2023

Study Start

October 18, 2021

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(13)