BIOmarkers and PLAtelet Function Assessment in Myocardial Ischemia and Non Obstructive Coronary Arteries Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Data extraction: After routine coronary function testing using a diagnostic pressure-temperature sensor guidewire in order to assess Coronary Flow Reserve (CFR) and the Index of Microvascular Resistance (IMR); and/or the acetylcholine (Ach) provocative test to assess the presence of coronary vasomotion disorders, patients will be stratified, accordingly to coronary function testing and Ach provocative test, in four groups/endotypes: 1. MVA (evidence of CMD defined as any of abnormal CFR \[\<2.0\], IMR \[≥25\], or microvascular spasm); 2. VSA (CFR ≥2.0, IMR \<25 and epicardial spasm); 3. both MVA and VSA (evidence of CMD and epicardial spasm); 4. none/non-cardiac chest pain (CFR ≥2.0 and IMR \<25 and neither microvascular nor epicardial spasm).

Blood sampling: At the time of this coronary angiography, arterial blood samples through the radial sheath will be collected. If collected at the time of any follow-up visit, venous blood samples will be collected by venipuncture with the same modalities to obtain whole blood, serum and plasma samples after centrifugation.

Clinical Follow-up: All patients will undergo a final follow-up visit at 12 months from the date of enrollment. During the visit, the incidence of MACE in the past months will be investigated, the Seattle Angina Questionnaire (SAQ) will be administered and the SAQ summary score will be collected.

Study summary

Ischemia with non-obstructive coronary artery disease (INOCA) identifies a significant proportion of patients presenting with signs and symptoms of myocardial ischemia with normal or near-normal coronary arteries at angiography. Initially believed a benign condition, it is now well-established that INOCA is associated with an increased risk for cardiovascular events. However, it is rarely correctly diagnosed. The identification of distinct signatures of circulating biomarkers and platelet alterations associated with the specific endotype of INOCA (Microvascular Angina \[MVA\]; Vasospastic Angina \[VSA\]; both MVA and VSA; and none) may help in the diagnosis of these patients as well as in the identification of specific pathophysiologic pathways and the development of future therapies. In addition, the identification of specific signatures may help in the prognostic stratification of INOCA patients, identifying those that may need more aggressive therapy and closer follow-up. Finally, the results deriving from this study may pave the way for a new pathophysiology-driven approach with cause-target therapies personalized for the specific mechanisms of INOCA. The BIOPLATINO study is the first study specifically designed to evaluate if there is a unique signature of circulating biomarkers and/or platelet function tests able to discriminate between the multiple pathogenetic mechanisms of INOCA as well as the different clinical courses. Furthermore, it may pave the way for the identification of specific pathophysiologic pathways of INOCA and the development of future therapies.

Eligibility

Primary outcome measure(s)

• Biomarker, miRNA and platelet function assessment for the specific endotype of INOCA — Up to 30 days
  Serum levels of circulating biomarkers, miRNAs and the results of platelet function tests as well as their combinations will be analyzed to evaluate sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the specific endotype of INOCA (MVA, VSA, both MVA and VSA, or none).

Trial sites (2)

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Spain