The main objective is to prospectively validate the capacity of continuous thermodilution coronary flow reserve (CFRflow) as a predictor of the presence of angina measured by SAQ7 in patients with INOCA at 3 months. Secondary objectives include identifying hemodynamic factors related to the persistence of angina at 3 and 12 months, identifying clinical factors associated with the persistence of angina, establishing the prevalence of patients with coronary microvascular dysfunction within the cohort of INOCA patients, identifying predictors of major cardiovascular events at 12 months, validating the pathological value of MMR and establishing the pathological value of AF measured in ml/min. The study also aims to evaluate the concordance between measures of the coronary microvascular function obtained by continuous thermodilution and bolus thermodilution, as well as their concordance with clinical characteristics.
Invasive study of microvascular function has become highly relevant for the diagnosis of alterations in coronary physiology for diagnostic, prognostic, and therapeutic purposes. Currently, the microvascular resistance index (IMR) is considered the gold standard for invasive diagnosis of coronary microvascular function, with a recommendation of 2A in the current clinical practice guidelines of the European Society of Cardiology. In recent years, technical innovation has allowed for the measurement of absolute coronary flow (AF) and minimal microvascular resistance (MMR) using continuous thermodilution, enabling the determination of quantitative flow and resistance units. However, the main limitation is the absence of reference values. Objectives: The main objective is to prospectively validate the capacity of CFRflow as a predictor of the presence of angina measured by SAQ7 in patients with INOCA at 3 months. Secondary objectives include identifying hemodynamic factors related to the persistence of angina at 3 and 12 months, identifying clinical factors related to the persistence of angina, establishing the prevalence of patients with coronary microvascular dysfunction within the cohort of INOCA patients, identifying predictors of major cardiovascular events at 12 months, validating the pathological value of MMR and establishing the pathological value of AF measured in ml/min. The study also aims to evaluate the concordance between measures of the coronary microvascular function obtained by continuous thermodilution and bolus thermodilution, as well as their concordance with clinical characteristics.
Study Type
OBSERVATIONAL
Enrollment
121
Diagnostic of Microvascular Coronary Dysfunction using continuous thermodilution flow reserve
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGHospital Clinic de Barcelona
Barcelona, Spain
RECRUITINGHospital del Mar
Barcelona, Spain
NOT_YET_RECRUITINGHospital Puerta del Mar
Cadiz, Spain
RECRUITINGHospital Universitario de La Princesa
Madrid, Spain
RECRUITINGHospital Ramón y Cajal
Madrid, Spain
RECRUITINGAngina Status
Angina Status assessed by Seattle Angina Questionnaire (SAQ).The total score is also transformed into a scale from 0 to 100, where a higher score indicates better angina-related quality of life.
Time frame: At inclusion
Quality of life at 3 months
Quality of life status in patients at 3 months post-diagnosis measured by the Seattle Angina Questionnaire (SAQ).The total score is also transformed into a scale from 0 to 100, where a higher score indicates better angina-related quality of life.
Time frame: 3 months
Accuracy of continuous thermodilution coronary flow reserve (CFR) measured by Youden Index = Sensitivity + Specificity - 1
Continuous thermodilution measured CFR flow and minimal microvascular resistance (MMR flow).
Time frame: At inclusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.