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 Type
OBSERVATIONAL
Enrollment
671
OLV Ziekenhuis Aalst
Aalst, Belgium
Righospitalet
Copenhagen, Denmark
The rate of MACCE between patients with and without CMD based on MRR at 1-year 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).
Time frame: 12 months follow-up
Relationship between MACCE's and each thermodilution- derived metrics of microvascular function
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)
Time frame: 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
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).
Time frame: 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
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).
Time frame: 12 months follow-up
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University of Mainz
Mainz, Germany
Catharina Hospital
Eindhoven, Netherlands
Radboud Hospital
Nijmegen, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
University Clinical Center of Serbia, University of Belgrade
Belgrade, Serbia
University Hospital Puerta del Mar
Cadiz, Spain
Clinica La Princesa
Madrid, Spain
San Carlos Hospital
Madrid, Spain
...and 9 more locations
Safety of continuous and bolus thermodilution measurements, as assessed by adverse event registration.
Safety of continuous and bolus thermodilution measurements, as assessed by adverse event registration.
Time frame: 12 months follow-up
To determine cut-off values of thermodilution-derived indices
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.
Time frame: 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)
To assess the prevalence of CMD based onMicrovascular Resistance Reserve (MRR) in patients with angina and non-obstructive coronary artery disease (NOCAD)
Time frame: 12 months follow-up