RNA as Prognostic Biomarkers in Patients With Acute Coronary Syndrome

NCT ID: NCT06058182

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-13

Study Completion Date

2027-01-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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blood draws

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Severe valve disease or other conditions requiring cardiac surgery
2. Previous cardiac surgery including coronary artery bypass grafts
3. Total chronic occlusions
4. Patients with known hypersensitivity or contraindication to any of the following drugs:

* heparin
* aspirin,
* clopidogrel,
* ticlopidine,
* sirolimus,
* everolimus.
5. Any contraindication to drug-eluting stent implantation (DES)
6. Patients with a documented history of myocardial infarction;
7. Left ventricular ejection fraction (LVEF) \<30% before PCI
8. Patients in cardiogenic shock
9. Patients with advanced ST-segment elevation myocardial infarction (\> 48 h from onset of symptoms/Q waves on electrocardiogram) or undergoing fibrinolysis;
10. Patients with prior known cardiomyopathy with LVEF \< 40%
11. Patients with malignant neoplasm or systemic disease with quoad vitam prognosis less than 1 year;
12. Patients with known active infectious diseases;
13. Patients who are unable to express valid informed consent to the act of enlistment
14. Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Policlinico S. Donato

OTHER

Sponsor Role lead

Responsible Party

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Luca Testa

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Policlinico S. Donato, Milan, Italy

Milan, Milan, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Luca Testa

Role: CONTACT

0252774987

Rossi Federica

Role: CONTACT

3337073714

Facility Contacts

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Luca Testa, MD, PhD, Contract Professor of

Role: primary

+39-2-52774980

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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RNA_ACS

Identifier Type: -

Identifier Source: org_study_id

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