BIOmarkers and PLAtelet Function Assessment in Myocardial Ischemia and Non Obstructive Coronary Arteries Study
BIOmarkers and PLAtelet Function Assessment in Myocardial Ischemia and Non Obstructive Coronary Arteries Study: The BIOplatINO Study
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
200 participants
Feb 1, 2022
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- Patients aged ≥ 18 years
- Patients diagnosed with INOCA
- Patients in therapy with acetylsalicylic acid (100 mg/die per os for more than 3 days or 250 mg intravenous in the past 3 days followed by 100 mg/die per os).
Exclusion Criteria2
- the use of thrombolytics, platelet glycoprotein (GP) IIb/IIIa blockers, oral anticoagulants, thienopyridine pretreatment, platelet counts outside the range of 125-450 10 9/l.
- comorbidities with an expected survival less than 1 year and contraindication to drugs administrated (e.g.: history of hypersensitivity to drugs administrated or its excipients, significant renal and/or hepatic disease).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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).
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.
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05714241