Clinical trial NCT06058182: RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome
Official title: RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Syndrome
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study, observational, prospective, single center that will make use of the recruitment of consecutive patients with acute coronary syndrome treated with angioplasty

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: identify circulating transcripts codifying and not for mRNA proteins, predictive of ventricular dysfunction in patients with acute coronary artery syndrome treated with coronary angioplasty.
timeFrame: 1 years
Secondary outcomes:
measure: 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.
timeFrame: 1 years
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Policlinico S. Donato, Milan, Italy
state: Milan
Study officials:
References: