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

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Syndrome
• Intervention / Treatment: Diagnostic test: blood draws

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 Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Luca Testa; Phone Number: 0252774987; Email: luca.testa@grupposandonato.it
• Study Contact Backup: Name: Rossi Federica; Phone Number: 3337073714; Email: federica.rossi@grupposandonato.it

Study Locations

• Italy
  • Milan
    • Milano, Milan, Italy, 20097
      • Recruiting
      • IRCCS Policlinico S. Donato, Milan, Italy
      • Contact: Luca Testa, MD, PhD, Contract Professor of; Phone Number: +39-2-52774980; Email: luctes@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 years

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: RNA_ACS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No