The Euro-CRAFT Registry

Study Overview
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Brief Summary
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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).

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

Conditions
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Coronary Microvascular Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of MACCE in presence of CMD defined according to thermodilution- derived metrics | 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) | 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 | 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. | 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. | 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 | 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 | 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. | 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 | 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 |