Coronary Microvascular Disease
Conditions
Brief summary
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).
Interventions
None listed
Sponsors
Hexacath, France
CoreAalst BV
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of MACCE between patients with and without CMD based on MRR at 1-year follow-up. | 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
| Measure | Time frame | Description |
|---|---|---|
| Relationship between the presence and severity of angina, assessed by SAQ- 19, and each individual thermodilution-derived metrics of microvascular function | 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). |
| Relationship between the presence and severity of angina, assessed by the ORIBTA Euro-CRAFT app, and each individual thermodilution-derived metrics of microvascular function | 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). |
| Relationship between MACCE's and each thermodilution- derived metrics of microvascular function | 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) |
| To determine cut-off values of thermodilution-derived indices | 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. |
| To assess the prevalence of Coronary Microvascular Disease based on Microvascular Resistance Reserve in patients with angina and non-obstructive coronary artery disease (NOCAD) | 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) |
| Safety of continuous and bolus thermodilution measurements, as assessed by adverse event registration. | 12 months follow-up | Safety of continuous and bolus thermodilution measurements, as assessed by adverse event registration. |
Countries
Belgium, Denmark, Germany, Netherlands, Serbia, Spain, Switzerland, United Kingdom
Outcome results
None listed