Belgian Registry on Coronary Function Testing

NCT ID: NCT06089031

Last Updated: 2023-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-18

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Microvascular Dysfunction Coronary Artery Vasospasm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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BELmicro

No intervention foreseen.

Coronary Function Test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Coronary Function Test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AZ Monica

Deurne, Antwerp, Belgium

Site Status RECRUITING

AZ Sint-Maarten

Mechelen, Antwerp, Belgium

Site Status RECRUITING

Jessa Hasselt

Hasselt, Limburg, Belgium

Site Status RECRUITING

OLV Aalst

Aalst, , Belgium

Site Status RECRUITING

Ziekenhuis aan de Stroom (ZAS)

Antwerp, , Belgium

Site Status RECRUITING

University Hospital Antwerp

Antwerp, , Belgium

Site Status RECRUITING

AZ Sint-Jan Brugge

Bruges, , Belgium

Site Status RECRUITING

AZ Jan Yperman

Ieper, , Belgium

Site Status RECRUITING

AZ Groeninge

Kortrijk, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

CHC Montlégia Liège

Liège, , Belgium

Site Status RECRUITING

CHR Citadelle Liège

Liège, , Belgium

Site Status RECRUITING

AZ Delta

Roeselare, , Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Bert Everaert, MD

Role: primary

0032 3 320 58 16

Maarten Kersemans, MD

Role: primary

003215 89 10 11

Peter Kayaert, MD, PhD

Role: primary

003211 37 35 65

Carlos B Collet, MD, PhD

Role: primary

003253 72 48 25

Carlo Zivelonghi, MD, PhD

Role: primary

+323 280 31 11

Tijs Bringmans, MD

Role: primary

+3238213843

Patrick Coussement, MD

Role: primary

0032 50 45 21 11

Mathieu Coeman, MD

Role: primary

0032 57 35 71 90

Carlos Van Mieghem, MD PhD

Role: primary

0032 56 63 31 00

Tom Adriaenssens, MD, PhD

Role: primary

+32 16 34 42 35

Pieter-Jan Palmers, MD

Role: primary

0032 4 355 50 30

Charles Pirlet, MD

Role: primary

0032 4 321 66 68

Maarten Van Haverbeke, MD PhD

Role: primary

0032 51 23 72 51

Other Identifiers

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2021-0522

Identifier Type: -

Identifier Source: org_study_id

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