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Identify circulating protein-coding (mRNAs) or non-coding (ncRNAs) transcripts (ACS_signature) predictive of ventricular dysfunction in ACS patients undergoing PCI.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood draws | Diagnostic Test | Pre-procedure, post-procedure (12-24 h), 6-month, and 12-month blood draws |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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
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Study, observational, prospective, single center that will make use of the recruitment of consecutive patients with acute coronary syndrome treated with angioplasty
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Testa | Contact | 0252774987 | luca.testa@grupposandonato.it | |
| Rossi Federica | Contact | 3337073714 | federica.rossi@grupposandonato.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico S. Donato, Milan, Italy | Recruiting | Milan | Milan | 20097 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 21, 2023 | Feb 28, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2023 | Sep 25, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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blood samples
| 1 years |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |