Microvascular AnginaEURO-ccraftNCT04598308
EUROpean Coronary microCirculatory Resistance and Absolute Flow Trial
An observational study of Microvascular Angina and Microvascular Coronary Artery Disease, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
Rationale: coronary microvascular disease is a relatively 'new' entity within the field of cardiology. The investigators are able to investigate the microcirculation by measurements performed in the catheterization laboratory. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Microvascular Angina, Microvascular Coronary Artery Disease, Coronary Vasospasm
- What is being tested?
- absolute flow and resistance measurements
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2020to 1 Oct 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: see above
Who may be able to join
- All patients are eligible for participation in this registry if they are undergoing coronary angiography with or without coronary intervention for any reason and if an indication for the foreseen intracoronary physiologic measurements is present according to the discretion of the investigating operator.
- >18 and <90 years of age
- able to give informed consent
Who cannot join
- There are no specific exclusion criteria other than contraindications for physiologic measurements in general.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Catharina Hospital
Eindhoven, North Brabant, 5623EJ
Nico Pijls, MD, PhD, 0402397000, nico.pijls@catharinaziekenhuis.nl
Danielle Keulards, MD, 0402397000, danielle.keulards@catharinaziekenhuis.nl
About this study
Official title: EUROpean Coronary microCirculatory Resistance and Absolute Flow Trial: An European Registry
Rationale: coronary microvascular disease is a relatively 'new' entity within the field of cardiology. The investigators are able to investigate the microcirculation by measurements performed in the catheterization laboratory. But even though measurements are performed on a daily basis, a lot of questions regarding microvascular disease remain. The rationale of this registry is to get an overview of patients and measurement values in daily routine practice.
Objective and main endpoint: No previous registries have been set-up where coronary blood flow and resistance was systematically stored. Therefore the analyses will be mainly descriptive. The objective is to acquire a better insight in the indications and use of this technique in everyday practice , its consequences for clinical decision making, and to enable interventionalists to exchange mutual knowledge about this specific methodology and about the coronary microcirculation in general.
Read more
Study design: prospective registry
Study population: All patients who underwent coronary angiography with or without coronary intervention for any reason and if an indication for the foreseen intracoronary physiologic measurements is present according to the discretion of the operator.
Intervention (if applicable): none, only usage of measurement data. The only 'intervention' for all patients is a questionnaire.
Read the detailed description
This registry only collects all measurement data from normal/routine physiologic assessment in the cathlab. These measurements are performed on a daily basis. The following paragraph will explain these routine measurements briefly.
Short description of the procedure Coronary angiography, PCI (if indicated), and physiologic measurements are performed completely according to normal routine. Physiologic measurements may include FFR, NHPR, IMR, CFR, absolute flow (Q) and microcirculatory resistance (Rmicro or MRR) measurement.
Intention to measure Q and Rmicro are mandatory to be included in this registry.
If there is failure to measure Q and/or Rmicro , it should be carefully noted including the reason for failure.
Coronary physiologic measurements may be performed either prior or after PCI, if applicable. If they are performed before PCI, it is recommended (according to Good Clinical Practice) but not absolutely mandatory to repeat these measurements also after PCI.
As said, the invasive procedure itself, including all measurements, should be performed completely according to clinical routine. Use of drugs either during or after the procedure should also exactly identical to normal routine.
- Conditions
- Microvascular Angina, Microvascular Coronary Artery Disease, Coronary Vasospasm, Microvascular Resistance
- Being tested
- absolute flow and resistance measurements
- Keywords
- coronary microvascular disease, ANOCA, epicardial spasm
- Medical subject headings
- Microvascular Angina, Coronary Vasospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
absolute flow and resistance measurementsDiagnostic test
This registry only collects all measurement data from normal/routine physiologic assessment in the cathlab. These measurements are performed on a daily basis
Short description of the procedure Coronary angiography, PCI (if indicated), and physiologic measurements are performed completely according to normal routine. Physiologic measurements may include FFR, NHPR, IMR, CFR, absolute flow (Q) and microcirculatory resistance (Rmicro or MRR) measurement.
Intention to measure Q and Rmicro are mandatory to be included in this registry.
Use of drugs either during or after the procedure should also exactly identical to normal routine.
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing invasive assessment of the microcirculation | All patients are eligible for participation in this registry if they are undergoing coronary angiography with or without coronary intervention for any reason and if an indication for the foreseen intracoronary physiologic measurements is present according to the discretion of the investigating operator. There are no specific exclusion criteria other than contraindications for physiologic measurements in general. Receives: Diagnostic Test: absolute flow and resistance measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical treatment assessment
change in clinical decision making after invasive assessment of the microcirculation
Measured: 1 year
Secondary outcomes (1)
IMR and resistance measurement
comparison between IMR and microvascular R measurements in WU
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Oct 2020
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular AnginaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Onze Lieve Vrouwziekenhuis Aalst
- Responsible party
- Principal investigator, Danielle Keulards, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598308
- Sponsor's protocol ID
- NL74650.100.20
- Acronym
- EURO-ccraft
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUROpean Coronary microCirculatory Resistance and Absolute Flow Trial: An European Registry
- ClinicalTrials.gov ID
- NCT04598308
- Acronym / sponsor ID
- EURO-ccraft / NL74650.100.20
- Conditions
- Microvascular Angina, Microvascular Coronary Artery Disease, Coronary Vasospasm, Microvascular Resistance
- Keywords
- coronary microvascular disease, ANOCA, epicardial spasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Onze Lieve Vrouwziekenhuis Aalst
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 22 Oct 2020 (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.
Rationale: coronary microvascular disease is a relatively 'new' entity within the field of cardiology. The investigators are able to investigate the microcirculation by measurements performed in the catheterization laboratory. But even though measurements are performed on a daily basis, a lot of questions regarding microvascular disease remain. The rationale of this registry is to get an overview of patients and measurement values in daily routine practice.
Objective and main endpoint: No previous registries have been set-up where coronary blood flow and resistance was systematically stored. Therefore the analyses will be mainly descriptive. The objective is to acquire a better insight in the indications and use of this technique in everyday practice , its consequences for clinical decision making, and to enable interventionalists to exchange mutual knowledge about this specific methodology and about the coronary microcirculation in general.
Study design: prospective registry
Study population: All patients who underwent coronary angiography with or without coronary intervention for any reason and if an indication for the foreseen intracoronary physiologic measurements is present according to the discretion of the operator.
Intervention (if applicable): none, only usage of measurement data. The only 'intervention' for all patients is a questionnaire.
Detailed description
This registry only collects all measurement data from normal/routine physiologic assessment in the cathlab. These measurements are performed on a daily basis. The following paragraph will explain these routine measurements briefly.
Short description of the procedure Coronary angiography, PCI (if indicated), and physiologic measurements are performed completely according to normal routine. Physiologic measurements may include FFR, NHPR, IMR, CFR, absolute flow (Q) and microcirculatory resistance (Rmicro or MRR) measurement.
Intention to measure Q and Rmicro are mandatory to be included in this registry.
If there is failure to measure Q and/or Rmicro , it should be carefully noted including the reason for failure.
Coronary physiologic measurements may be performed either prior or after PCI, if applicable. If they are performed before PCI, it is recommended (according to Good Clinical Practice) but not absolutely mandatory to repeat these measurements also after PCI.
As said, the invasive procedure itself, including all measurements, should be performed completely according to clinical routine. Use of drugs either during or after the procedure should also exactly identical to normal routine.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing invasive assessment of the microcirculation | – | Diagnostic Test: absolute flow and resistance measurementsAll patients are eligible for participation in this registry if they are undergoing coronary angiography with or without coronary intervention for any reason and if an indication for the foreseen intracoronary physiologic measurements is present according to the discretion of the investigating operator. There are no specific exclusion criteria other than contraindications for physiologic measurements in general. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- see above
Key inclusion criteria (3 listed)
- All patients are eligible for participation in this registry if they are undergoing coronary angiography with or without coronary intervention for any reason and if an indication for the foreseen intracoronary physiologic measurements is present according to the discretion of the investigating operator.
- >18 and <90 years of age
- able to give informed consent
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria other than contraindications for physiologic measurements in general.
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 |
|---|---|---|
| absolute flow and resistance measurementsThis registry only collects all measurement data from normal/routine physiologic assessment in the cathlab. These measurements are performed on a daily basis Short description of the procedure Coronary angiography, PCI (if indicated), and physiologic measurements are performed completely according to normal routine. Physiologic measurements may include FFR, NHPR, IMR, CFR, absolute flow (Q) and microcirculatory resistance (Rmicro or MRR) measurement. Intention to measure Q and Rmicro are mandatory to be included in this registry. Use of drugs either during or after the procedure should also exactly identical to normal routine. | Diagnostic test | patients undergoing invasive assessment of the microcirculation |
Primary outcome
clinical treatment assessment
Time frame: 1 year
change in clinical decision making after invasive assessment of the microcirculation
1 secondary outcome
IMR and resistance measurement
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microvascular Angina and Microvascular Coronary Artery Disease, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danielle Keulards, MD (0031402397000, danielle.keulards@catharinaziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical treatment assessment (time frame: 1 year). 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 22 Oct 2020.