Assessing biomarkers and platelet function in patients with myocardial ischemia and non-obstructive coronary arteries
Official title: BIOmarkers and PLAtelet Function Assessment in Myocardial Ischemia and Non Obstructive Coronary Arteries Study: The BIOplatINO Study
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05714241 · Data updated 2026-11-12
This study is trying to find specific blood markers and how platelets work in people with heart pain caused by non-blocked arteries to help improve diagnosis and treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 2 sites (Rome and 1 other locations) |
| Status | Recruiting |
| Started | February 1, 2022 |
| Main results expected | March 1, 2025 |
| Study ends | March 1, 2027 |
| Registry record updated | February 26, 2024 |
| Trial ID | NCT05714241 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who have been diagnosed with INOCA and are currently receiving acetylsalicylic acid therapy.
✕Probably not a fit
Patients with significant comorbidities that limit their life expectancy to less than one year or those with contraindications to the study medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients diagnosed with ischemia and non-obstructive coronary artery disease (INOCA), a condition that is often misdiagnosed despite being linked to significant cardiovascular risks. The study aims to identify specific circulating biomarkers and platelet function alterations associated with different endotypes of INOCA, such as microvascular angina and vasospastic angina. By analyzing these biomarkers, the research seeks to improve diagnostic accuracy and prognostic stratification, potentially guiding more aggressive therapies for at-risk patients. Data will be collected through blood sampling and clinical follow-up to understand the underlying pathophysiological mechanisms better.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment strategies for patients suffering from INOCA, ultimately reducing their risk of serious cardiovascular events.
How similar studies have gone: While the approach of identifying biomarkers in INOCA is gaining attention, this specific study's methodology and focus on platelet function represent a novel exploration in this area.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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).
Where it's running
-
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy Recruiting -
Hospital Clínic Cardiovascular Institute
Barcelona, Spain Recruiting
Study contacts
- Principal investigator: Rocco A Montone, MD, PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Rocco A Montone, MD, PhD
- Email: roccoantonio.montone@policlinicogemelli.it
- Phone: +39-0630154187
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.