RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome (RNAacs)

San Donato Group (GSD)

Status: Enrolling

Conditions: Coronary Syndrome

Treatments: Diagnostic Test: blood draws

Study type: Observational

Funder types: Other

Identifiers

NCT06058182

RNA_ACS

Details and patient eligibility

About

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

Full description

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design