The Euro-CRAFT Registry (Euro-CRAFT)

March 27, 2023 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

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

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

Study Contact

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Recruiting
        • OLV Ziekenhuis Aalst
        • Principal Investigator:
          • Bernard De Bruyne, MD, PhD
        • Contact:
          • Hilde Delacroix
  • Netherlands
      • Eindhoven, Netherlands
        • Recruiting
        • Catharina Hospital
        • Contact:
          • Danielle Keulards
        • Principal Investigator:
          • Annemiek De Vos
  • Spain
      • Madrid, Spain
        • Recruiting
        • Clinica La Princesa
        • Contact:
          • Fernando Rivero
        • Principal Investigator:
          • Fernando Rivero

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

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
Rate of MACCE in presence of CMD defined according to thermodilution- derived metrics
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) in the presence of coronary microvascular dysfunction (CMD) defined according to thermodilution derived metrics (bolus and continuous).
12 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The presence and severity of angina according to bolus thermodilution derived index microcirculatory resistance (IMR) and coronary flow reserve (CFR)
Time Frame: 12 months follow-up
The presence and severity of angina, assessed by the Seattle Angina Questionnaire 19 (SAQ-19) according to bolus thermodilution derived index microcirculatory resistance (IMR) and coronary flow reserve (CFR)
12 months follow-up
The rate of MACCE according to bolus thermodilution derived IMR and CFR
Time Frame: 12 Months follow-up
the rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) according to bolus thermodilution derived Index Microcirculatory Resistance (IMR) and Coronary Flow Reserve (CFR)
12 Months follow-up
The presence and severity of angina according to bolus thermodilution-derived single injection IMR.
Time Frame: 12 Months follow-up
The presence and severity of angina according to bolus thermodilution-derived single injection Index Microcirculatory Resistance (IMR).
12 Months follow-up
The rate of MACCE according to bolus thermodilution-derived single injection IMR.
Time Frame: 12 Months follow-up
The rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) according to bolus thermodilution-derived single injection Index Microcirculatory Resistance (IMR).
12 Months follow-up
The severity of angina, assessed by SAQ-19 in presence of CMD defined according to individual continuous thermodilution-derived indices
Time Frame: 12 Months follow-up
The severity of angina, assessed by the Seattle Angina Questionnaire (SAQ-19) in presence of Coronary Microvascular Dysfunction (CMD) defined according to individual continuous thermodilution-derived indices (absolute coronary flow at rest, absolute coronary flow during hyperemia, microvascular resistance at rest, microvascular resistance during hyperemia, microvascular resistance reserve, coronary flow reserve)
12 Months follow-up
The rate of MACCE according to individual continuous and bolus thermodilution-derived indices
Time Frame: 12 Months follow-up
The rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) according to individual continuous and bolus thermodilution-derived indices (Index of Microcirculatory Resistance, absolute coronary flow at rest, absolute coronary flow during hyperemia, microvascular resistance at rest, microvascular resistance during hyperemia, microvascular resistance reserve, coronary flow reserve)
12 Months follow-up
The severity of angina, assessed by the ORBITA app, according to bolus thermodilution-derived IMR and CFR.
Time Frame: 12 Months Follow-up
The severity of angina, assessed by the ORBITA app, according to bolus thermodilution-derived Index Microcirculatory Resistance (IMR) and Coronary Flow Reserve (CFR).
12 Months Follow-up
The severity of angina, assessed by the ORBITA app according to individual continuous thermodilution-derived indices
Time Frame: 12 months Follow-up
The severity of angina, assessed by the ORBITA app according to individual continuous thermodilution-derived indices (absolute coronary flow at rest, absolute coronary flow during hyperemia, microvascular resistance at rest, microvascular resistance during hyperemia, microvascular resistance reserve, coronary flow reserve)
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 (Anticipated)

September 22, 2025

Study Completion (Anticipated)

September 22, 2029

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 (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRI-080

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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