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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Coronary Syndrome

Treatments: Other: blood sample collection

Study type: Observational

Funder types: Other

Identifiers

NCT06103357

INRCA_009_2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

20 participants in 1 patient group

subjects with clinical indication for coronary angioplasty

Description:

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

Treatment:

Other: blood sample collection