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

Identification of Innovative Circulating and Cellular Biomarkers in Subjects With Acute and Chronic Coronary Syndrome (PLAQUE Study)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06103357
Acronym
PLAQUE
Enrollment
20
Registered
2023-10-26
Start date
2023-03-06
Completion date
2024-04-30
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Syndrome

Keywords

Acute Coronary Syndrome, Chronic Coronary Syndrome, microRNAs, soluble ST2, interleukin-6

Brief summary

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

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.

Interventions

OTHERblood 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.

Sponsors

Ministry of Health, Italy
CollaboratorOTHER_GOV
Istituto Nazionale di Ricovero e Cura per Anziani
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

MeasureTime frameDescription
miRNome analysisbaselineThe Next Generation Sequencing (NGS) techniques will be used to identify miRNome picture as potential biomarkers for acute and chronic coronary syndrome.

Secondary

MeasureTime frameDescription
Identification of biomarkers of inflammationbaselineInterleukin-6 and soluble ST2 levels will be assessed in plasma samples.

Countries

Italy

Contacts

Primary ContactAnna Rita Bonfigli, PhD
a.bonfigli@inrca.it0718003719

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026