RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome

IRCCS Policlinico S. Donato70 enrolled

Overview

Identify circulating protein-coding (mRNAs) or non-coding (ncRNAs) transcripts (ACS\_signature) predictive of ventricular dysfunction in ACS patients undergoing PCI.

Perform an observational, prospective study involving the evaluation of circulating biomarkers predictive of ventricular dysfunction (FE \<45%) in patients with ACS. In particular, will be to verify whether there are circulating transcripts in peripheral blood, coding or not for proteins (mRNAs or ncRNAs), modulated differently in patients with ACS (ACS\_signature) undergoing PCI, distinguished on the basis of evolution towards ventricular dysfunction. The study will be based on whole genome transcriptomic analysis.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Syndrome

Interventions

blood drawsDIAGNOSTIC_TEST

Pre-procedure, post-procedure (12-24 h), 6-month, and 12-month blood draws

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \>18 years 2. Patients with ACS (first episode), defined according to the guidelines of the European Society of Cardiology (ESC) 2017 3. Indication for percutaneous revascularization treatment 4. Informed consent to study enrollment Exclusion Criteria: 1. Severe valve disease or other conditions requiring cardiac surgery 2. Previous cardiac surgery including coronary artery bypass grafts 3. Total chronic occlusions 4. Patients with known hypersensitivity or contraindication to any of the following drugs: * heparin * aspirin, * clopidogrel, * ticlopidine, * sirolimus, * everolimus. 5. Any contraindication to drug-eluting stent implantation (DES) 6. Patients with a documented history of myocardial infarction; 7. Left ventricular ejection fraction (LVEF) \<30% before PCI 8. Patients in cardiogenic shock 9. Patients with advanced ST-segment elevation myocardial infarction (\> 48 h from onset of symptoms/Q waves on electrocardiogram) or undergoing fibrinolysis; 10. Patients with prior known cardiomyopathy with LVEF \< 40% 11. Patients with malignant neoplasm or systemic disease with quoad vitam prognosis less than 1 year; 12. Patients with known active infectious diseases; 13. Patients who are unable to express valid informed consent to the act of enlistment 14. Pregnant women

Locations (1)

IRCCS Policlinico S. Donato, Milan, Italy

Milan, Milan, Italy

RECRUITING

Outcomes

Primary Outcomes

identify circulating transcripts codifying and not for mRNA proteins, predictive of ventricular dysfunction in patients with acute coronary artery syndrome treated with coronary angioplasty.

For discovery activities using RNA-sequencing, based on literature data, we assume a sample size of 40 patients (20 per group) that will allow to evaluate the 40 transcripts that differentiate patients with ventricular dysfunction and not ventricular dysfunction, out of a total of 17,500 tests, with a power of 94.0 %, an FDR value of 0.02. For qPCR validation activities, a power of 95% is obtained by analyzing 50 samples per group by evaluating differences between the averages of 2,2 times, with α= 0,01 and σ= 1,4.

Time frame: 1 years

Secondary Outcomes

Evaluate the association of the ACS_signature with possible adverse events at 12 months and its prognostic ability in the prediction of adverse events additional to the use of standard clinical parameters.

Adverse events are defined: death from cardiovascular causes, re infarction, non-fatal stroke, new coronary revascularization, arrhythmias, development of heart failure and new hospitalizations for cardiovascular causes

Time frame: 1 years

Central Contacts

Luca Testa

CONTACT

0252774987 luca.testa@grupposandonato.it

Rossi Federica

CONTACT

3337073714 federica.rossi@grupposandonato.it

Data from ClinicalTrials.gov

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