The Euro-CRAFT Registry (Euro-CRAFT)

January 9, 2026 updated by: CoreAalst BV

European microCirculatory Resistance and Absolute Flow Team: The Euro-CRAFT Registry

The Euro-CRAFT Registry is a prospective, multicentric, international registry of patients undergoing functional assessment of the coronary microcirculation using the continuous thermodilution technique. Angina and quality of life questionnaires (Seattle Angina Questionnaire 19 - SAQ19, ORBITA app) will be obtained at baseline, at 6 months, and 1-year follow-up. Clinical follow-up will be performed at 1 year (optionally until 5 years).

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

671

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • OLV Ziekenhuis Aalst
  • Denmark
      • Copenhagen, Denmark
        • Righospitalet
  • Germany
      • Mainz, Germany
        • University of Mainz
  • Netherlands
      • Eindhoven, Netherlands
        • Catharina Hospital
      • Nijmegen, Netherlands
        • Radboud Hospital
      • Rotterdam, Netherlands
        • Maasstad Ziekenhuis
  • Serbia
      • Belgrade, Serbia
        • University Clinical Center of Serbia, University of Belgrade
  • Spain
      • Cadiz, Spain
        • University Hospital Puerta del Mar
      • Madrid, Spain
        • San Carlos Hospital
      • Madrid, Spain
        • Clinica La Princesa
  • Switzerland
      • Lausanne, Switzerland
        • University Hospital Lausanne
  • United Kingdom
      • Bath, United Kingdom
        • Royal United Hospital Bath NHS Foundation Trust
      • Bristol, United Kingdom
        • Bristol Heart Institute
      • Essex, United Kingdom
        • Basildon Hospital
      • Glasgow, United Kingdom
        • Golden Jubilee National Hospital
      • London, United Kingdom
        • Royal Brompton Hospital
      • London, United Kingdom
        • Imperial College
      • London, United Kingdom
        • St. Thomas Hospital, King's College
      • Oxford, United Kingdom
        • Oxford University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Consecutive patients in whom physiological assessment of the microcirculatory function including continuous coronary thermodilution has been performed with a Pressure-wire X within the context of routine clinical care.

Description

Inclusion Criteria:

  • Age > 18 years.
  • Stable patients should have complaints of chest pain suspected of angina pectoris or other symptoms raising the suspicion of IHD and non-obstructive epicardial coronary arteries on invasive coronary angiography (ICA, diameter stenosis of less than 50%) with an FFR >0.80.
  • Any other clinical scenario (including in the context of ACS) prompting the physician to assess the function of the coronary microvasculature.

Exclusion Criteria:

  • Unable to provide consent
  • Unstable hemodynamics
  • Ongoing chest pain.
  • Previous CABG
  • Moderate to severe valvular heart disease
  • Uncontrolled or recurrent ventricular tachycardia.
  • Active liver disease or hepatic dysfunction, defined as AST or ALT > 3 times the ULN.
  • Comorbidity with life expectancy <= 2 years.
  • Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2.
  • Subject is currently participating in another investigational drug or device clinical study.
  • Presence of other anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of MACCE between patients with and without CMD based on MRR at 1-year follow-up.
Time Frame: 12 months follow-up
Rate of Major Adverse Cardiac and Cerebrovascular Events at one year (MACCE defined as cardiovascular death, angina and heart failure related hospitalisations and stroke) between patients with and without Coronary Microvascular Disease (CMD) defined according to thermodilution derived metrics (Microvascular Resistance Reserve, MRR).
12 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between MACCE's and each thermodilution- derived metrics of microvascular function
Time Frame: 12 months follow-up
Relationship between Major Adverse Cardiac and Cerebrovascular Events (MACCE defined as cardiovascular death, angina and heart failure related hospitalisations and stroke) and each thermodilution-derived metrics of microvascular function (i.e. absolute hyperemic flow, absolute hyperemic resistance, Index of Microvascular Resistance, and Coronary Flow Reserve)
12 months follow-up
Relationship between the presence and severity of angina, assessed by SAQ- 19, and each individual thermodilution-derived metrics of microvascular function
Time Frame: 12 months follow-up
Relationship between the presence and severity of angina, assessed by Seattle Angina Questionnaire 19, and each individual thermodilution-derived metrics of microvascular function (i.e., absolute hyperemic flow, absolute hyperemic resistance,Index of Microvascular Resistance and Coronary Flow Reserve).
12 months follow-up
Relationship between the presence and severity of angina, assessed by the ORIBTA Euro-CRAFT app, and each individual thermodilution-derived metrics of microvascular function
Time Frame: 12 months follow-up
Relationship between the presence and severity of angina, assessed by the ORBITA Euro-CRAFT app, and each individual thermodilution-derived metrics of microvascular function (i.e., absolute hyperemic flow, absolute hyperemic resistance, Index of Microvascular Resistance and Coronary Flow Reserve).
12 months follow-up
Safety of continuous and bolus thermodilution measurements, as assessed by adverse event registration.
Time Frame: 12 months follow-up
Safety of continuous and bolus thermodilution measurements, as assessed by adverse event registration.
12 months follow-up
To determine cut-off values of thermodilution-derived indices
Time Frame: 12 months follow-up
To determine cut-off values of thermodilution-derived indices (i.e. absolute hyperemic flow, absolute hyperemic resistance, Index of Microvascular Resistance and Coronary Flow Reserve to assess the presence of Coronary Microvascular Disease.
12 months follow-up
To assess the prevalence of Coronary Microvascular Disease based on Microvascular Resistance Reserve in patients with angina and non-obstructive coronary artery disease (NOCAD)
Time Frame: 12 months follow-up
To assess the prevalence of CMD based onMicrovascular Resistance Reserve (MRR) in patients with angina and non-obstructive coronary artery disease (NOCAD)
12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CoreAalst BV

Collaborators

Hexacath, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2022

Primary Completion (Estimated)

September 22, 2026

Study Completion (Estimated)

September 22, 2030

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRI-080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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