RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome

Coronary Syndrome Clinical Trial

— RNAacs  

Official title:

RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058182
• Other study ID #: RNA_ACS
• Status: Recruiting
• Start date: July 13, 2020
• Est. completion date: January 30, 2027

Study information

• Verified date: October 2023
• Source: IRCCS Policlinico S. Donato
• Contact: Luca Testa
• Phone: 0252774987
• Email: luca.testa[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 30, 2027
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Syndrome
• Syndrome

Intervention

Diagnostic Test:
• blood draws
Pre-procedure, post-procedure (12-24 h), 6-month, and 12-month blood draws

Locations

Country	Name	City	State
Italy	IRCCS Policlinico S. Donato, Milan, Italy	Milano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 a= 0,01 and s= 1,4.	1 years
Secondary	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