RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome
ConditionCoronary Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Policlinico S. Donato
About this trial
Identify circulating protein-coding (mRNAs) or non-coding (ncRNAs) transcripts (ACS\_signature) predictive of ventricular dysfunction in ACS patients undergoing PCI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Severe valve disease or other conditions requiring cardiac surgery
Previous cardiac surgery including coronary artery bypass grafts
Total chronic occlusions
heparin
Trial population
Study, observational, prospective, single center that will make use of the recruitment of consecutive patients with acute coronary syndrome treated with angioplasty
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
blood draws
Diagnostic testPre-procedure, post-procedure (12-24 h), 6-month, and 12-month blood draws
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
1 yearsSecondary 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.
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
Time frame
1 yearsSponsors and contacts
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Source ClinicalTrials.gov