RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome

Recruiting

• Conditions: Coronary Syndrome

• Registration Number: NCT06058182
• Lead Sponsor: IRCCS Policlinico S. Donato

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.

Study Timeline

• Study Start: 2020-07-13
• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-09-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-06
• Primary Completion: 2026-01-30
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
identify circulating transcripts codifying and not for mRNA proteins, predictive of ventricular dysfunction in patients with acute coronary artery syndrome treated with coronary angioplasty.	1 years	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.

Secondary Outcome Measures

Name	Time	Method
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.	1 years	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

Trial Locations

Locations (1)

IRCCS Policlinico S. Donato, Milan, Italy; 🇮🇹 Milano, Milan, Italy