Identification of Biomarkers in Subjects With Coronary Syndrome (PLAQUE Study)

NCT ID: NCT06103357

Last Updated: 2024-03-05

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

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-06

Study Completion Date

2024-04-30

Brief Summary

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The study will to test the levels of innovative biomarkers, such as miRNAs, in the blood of subjects underwent to angioplasty procedure according to standard clinical practice.

Detailed Description

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Twenty patients with acute coronary syndrome from non-ST-segment elevation myocardial infarction or with chronic coronary syndrome with clinical indication and favorable anatomy for coronary angioplasty will be enrolled. The angioplasty procedure will be performed according to standard clinical practice. Before and after angioplasty, blood samples will be taken upstream and downstream of the coronary lesion, arterial sampling will be performed at the level of the aortic root, and peripheral venous blood will be collected. MicroRNA expression will be analyzed in serum by next-generation sequencing (miRNome). Quantitative analysis of pro- and anti-inflammatory molecules such as IL-6 and the soluble form of IL-33 receptor (sST2) will be performed on various blood samples.

Conditions

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Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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subjects with clinical indication for coronary angioplasty

Twenty subjects with acute or chronic coronary syndrome that will be underwent to angioplasty procedure according to standard clinical practice.

blood sample collection

Intervention Type OTHER

Before and after angioplasty, blood samples upstream and downstream of the coronary lesion will be taken, arterial sampling at the aortic root level will be performed, and peripheral venous blood will be collected.

Interventions

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blood sample collection

Before and after angioplasty, blood samples upstream and downstream of the coronary lesion will be taken, arterial sampling at the aortic root level will be performed, and peripheral venous blood will be collected.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical indication for the PCI procedure according to the latest ESC (European Society of Cardiology) Guidelines
* Coronary stenosis treated with angioplasty must be located in the proximal segments of the three main vessels: IVA, CX and CD
* The vessels must have a diameter of their mid-distal section ≥ 3 mm
* Patients with NSTEMI ACS and clinical indication with favorable anatomy for coronary angioplasty, also called percutaneous coronary intervention (PCI), (for the ACS group)
* Patients with clinically incipient SCC with stable angina (or significant anginal equivalents) and clinical indication with favorable anatomy for PCI (for the SCC group)

Exclusion Criteria

* Contraindications to anticoagulant/antiplatelet therapy
* Extensive calcifications and/or tortuosity of the major epicardial segments
* Evidence of thrombotic occupation
* Patients with hemodynamic instability
* Patients with EF (ejection fraction) \< 35%
* Patients with severe chronic renal failure (e-GFR \< 30 mL/min)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Italy

OTHER_GOV

Sponsor Role collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roberto Antonicelli, MD

Role: STUDY_DIRECTOR

IRCCS INRCA

Locations

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IRCCS INRCA Hospital

Ancona, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Anna Rita Bonfigli, PhD

Role: CONTACT

0718003719

Facility Contacts

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Olga Protic, PhD

Role: primary

References

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Protic O, Bonfigli AR, Olivieri F, Lamedica AM, Gabrielli G, Antonicelli R. miRNome profile in blood samples upstream and downstream of the coronary lesion and arterial aortic root before and after angioplasty in subjects with chronic and acute coronary syndrome: A pilot observational study protocol (Plaque study). PLoS One. 2025 Jun 13;20(6):e0324467. doi: 10.1371/journal.pone.0324467. eCollection 2025.

Reference Type DERIVED
PMID: 40512691 (View on PubMed)

Other Identifiers

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INRCA_009_2023

Identifier Type: -

Identifier Source: org_study_id

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