Coronary Microvascular DysfunctionBELmicroNCT06089031
Belgian Registry on Coronary Function Testing
An observational study of Coronary Microvascular Dysfunction and Coronary Artery Vasospasm, run by University Hospital, Antwerp at 13 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Microvascular Dysfunction, Coronary Artery Vasospasm
- What is being tested?
- Coronary Function Test
- How many people
- 650 participants
- Where
- 13 sitesBelgium
- Study dates
- 18 Oct 2021to 31 Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Belgium13 sites, 13 recruiting
- Recruiting
OLV Aalst
Aalst, 9300
Carlos B Collet, MD, PhD, 003253 72 48 25, carlos.collet.bortone@olvz-aalst.be
- Recruiting
Ziekenhuis aan de Stroom (ZAS)
Antwerp, 2020
Carlo Zivelonghi, MD, PhD, +323 280 31 11, carlo.zivelonghi@zas.be
Alice Benedetti, MD
- Recruiting
University Hospital Antwerp
Antwerp, 2650
Tijs Bringmans, MD, +3238213843, tijs.bringmans@uza.be
Vincent FM Segers, MD, PhD
- Recruiting
AZ Sint-Jan Brugge
Bruges, 8000
Patrick Coussement, MD, 0032 50 45 21 11, patrick.coussement@azsintjan.be
- Recruiting
AZ Monica
Deurne, Antwerp, 2100
Bert Everaert, MD, 0032 3 320 58 16, bert.everaert@azmonica.be
- Recruiting
Jessa Hasselt
Hasselt, Limburg, 3500
Peter Kayaert, MD, PhD, 003211 37 35 65, peter.kayaert@jessazh.be
- Recruiting
AZ Jan Yperman
Ieper, 8900
Mathieu Coeman, MD, 0032 57 35 71 90, mathieu.coeman@yperman.net
- Recruiting
AZ Groeninge
Kortrijk, 8500
Carlos Van Mieghem, MD PhD, 0032 56 63 31 00, hartcentrum@azgroeninge.be
- Recruiting
UZ Leuven
Leuven, 3000
Tom Adriaenssens, MD, PhD, +32 16 34 42 35, tom.adriaenssens@uzleuven.be
- Recruiting
CHC Montlégia Liège
Liège, 4000
Pieter-Jan Palmers, MD, 0032 4 355 50 30, pieter-jan.palmers@chc.be
- Recruiting
CHR Citadelle Liège
Liège
Charles Pirlet, MD, 0032 4 321 66 68, charles.pirlet@chrcitadelle.be
- Recruiting
AZ Sint-Maarten
Mechelen, Antwerp, 2800
Maarten Kersemans, MD, 003215 89 10 11, maarten.kersemans@emmaus.be
- Recruiting
AZ Delta
Roeselare, 8800
Maarten Van Haverbeke, MD PhD, 0032 51 23 72 51, maarten.vanhaverbeke@azdelta.be
About this study
Official title: 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.
- Being tested
- Coronary Function Test
- Medical subject headings
- Coronary Vasospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Function TestDiagnostic test
Coronary function test may comprise of bolus thermodilution measurements of coronary microvascular function and/or acetylcholine-derived coronary vasoreactivity tests.
| Study group | Role | What they receive |
|---|---|---|
| BELmicro | No intervention foreseen. Receives: Diagnostic Test: Coronary Function Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (2)
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.
Measured: 5 years
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start18 Oct 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089031
- Sponsor's protocol ID
- 2021-0522
- Acronym
- BELmicro
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Registry on Coronary Function Tests, Organized by the Belgian Working Group on Coronary Microcirculation/Belgian Microcirculation Registry.
- ClinicalTrials.gov ID
- NCT06089031
- Acronym / sponsor ID
- BELmicro / 2021-0522
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BELmicro | – | Diagnostic Test: Coronary Function TestNo intervention foreseen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Function TestCoronary function test may comprise of bolus thermodilution measurements of coronary microvascular function and/or acetylcholine-derived coronary vasoreactivity tests. | Diagnostic test | BELmicro |
Primary outcome
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.
2 secondary outcomes
Describe predictors for coronary microvascular dysfunction and/or coronary artery vasospasm
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Microvascular Dysfunction and Coronary Artery Vasospasm, run by University Hospital, Antwerp at 13 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of coronary microvascular dysfunction and/or coronary artery vasospasm (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.