Actively Recruiting

Age: 18Years +
All Genders
NCT05714241

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

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-02-26

200

Participants Needed

2

Research Sites

264 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 65 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).
Not Eligible

You will not qualify if you...

  • Use of thrombolytics, platelet glycoprotein IIb/IIIa blockers, oral anticoagulants, thienopyridine pretreatment, or platelet counts outside 125-450 x 10^9/L
  • Comorbidities with expected survival less than 1 year
  • Contraindications to administered drugs such as hypersensitivity or significant renal or hepatic disease

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy, 00168

Actively Recruiting

2

Hospital Clínic Cardiovascular Institute

Barcelona, Spain

Actively Recruiting

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Research Team

R

Rocco A Montone, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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