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NCT Number: NCT06058182

RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico S. Donato, Milan, Italy

Milan, 20097, Italy

Location status: Recruiting

Location contact

Luca Testa, MD, PhD, Contract Professor of

CONTACT

[email protected]

+39-2-52774980

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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;
  • Patients with prior known cardiomyopathy with LVEF < 40%
  • Patients with malignant neoplasm or systemic disease with quoad vitam prognosis less than 1 year;
  • Patients with known active infectious diseases;
  • Patients who are unable to express valid informed consent to the act of enlistment
  • Pregnant women

Treatment and study plan

Blood draws

Diagnostic Test

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

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.

    Time frame: 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 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.

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Testa

CONTACT

[email protected]

0252774987

Rossi Federica

CONTACT

[email protected]

3337073714

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Registry information

Acronym: RNAacs

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Sep 28, 2023
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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