RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood draws.
- Who it may be relevant to
- Registry conditions: Coronary Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test blood draws
Pre-procedure, post-procedure (12-24 h), 6-month, and 12-month blood draws
Primary outcome measures
- 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]
Secondary outcome measures (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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- IRCCS Policlinico S. Donato, Milan, Italy — Milan
Identifiers
NCT: NCT06058182 · RNA_ACS