RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome

NCT06058182 | Recruiting

• 1 other identifier: RNA_ACS
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

blood draws DIAGNOSTIC_TEST

Pre-procedure, post-procedure (12-24 h), 6-month, and 12-month blood draws

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age \>18 years
• Patients with ACS (first episode), defined according to the guidelines of the European Society of Cardiology (ESC) 2017
• Indication for percutaneous revascularization treatment
• Informed consent to study enrollment

You may not qualify if:

• Severe valve disease or other conditions requiring cardiac surgery
• Previous cardiac surgery including coronary artery bypass grafts
• Total chronic occlusions
• Patients with known hypersensitivity or contraindication to any of the following drugs:
• heparin
• aspirin,
• clopidogrel,
• ticlopidine,
• sirolimus,
• everolimus.
• Any contraindication to drug-eluting stent implantation (DES)
• Patients with a documented history of myocardial infarction;
• Left ventricular ejection fraction (LVEF) \<30% before PCI
• Patients in cardiogenic shock
• Patients with advanced ST-segment elevation myocardial infarction (\> 48 h from onset of symptoms/Q waves on electrocardiogram) or undergoing fibrinolysis;

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico S. Donato, Milan, Italy

Milan, Milan, 20097, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Angina, Unstable

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Luca Testa

CONTACT

0252774987; luca.testa@grupposandonato.it

Rossi Federica

CONTACT

3337073714; federica.rossi@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: September 28, 2023
• Study Start: July 13, 2020
• Primary Completion: January 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

IT (1)