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EUROpean Coronary microCirculatory Resistance and Absolute Flow Trial

EUROpean Coronary microCirculatory Resistance and Absolute Flow Trial: An European Registry

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04598308
Acronym
EURO-ccraft
Enrollment
200
Registered
2020-10-22
Start date
2020-10-01
Completion date
2023-10-01
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Vasospasm, Microvascular Angina, Microvascular Coronary Artery Disease, Microvascular Resistance

Keywords

coronary microvascular disease, ANOCA, epicardial spasm

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTabsolute flow and resistance measurements

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.

Sponsors

Onze Lieve Vrouwziekenhuis Aalst
CollaboratorOTHER
Catharina Ziekenhuis Eindhoven
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

\- There are no specific

Design outcomes

Primary

MeasureTime frameDescription
clinical treatment assessment1 yearchange in clinical decision making after invasive assessment of the microcirculation

Secondary

MeasureTime frameDescription
IMR and resistance measurement2 yearscomparison between IMR and microvascular R measurements in WU

Countries

Netherlands

Contacts

Primary ContactDanielle Keulards, MD
danielle.keulards@catharinaziekenhuis.nl0031402397000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026