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NCT Number: NCT05805462

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Coronary Microvascular Disease Angina Pectoris Cardiovascular Diseases Heart Diseases Microvascular Angina Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OLV Ziekenhuis Aalst, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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)

Sponsors and collaborators

Lead sponsor

CoreAalst BV

Industry

Collaborators

  • Hexacath, France

Registry information

Official study title

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

Acronym: Euro-CRAFT

Important dates

Study start
2022
Primary completion
2026
Study completion
2030
First posted
Apr 10, 2023
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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