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

Recruiting

• Conditions: Coronary Syndrome
• Interventions: Other: blood sample collection

• Registration Number: NCT06103357
• Lead Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani

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.

Study Timeline

• Study Start: 2023-03-06
• Status Verified: 2023-10
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-26
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
subjects with clinical indication for coronary angioplasty	blood sample collection	Twenty subjects with acute or chronic coronary syndrome that will be underwent to angioplasty procedure according to standard clinical practice.

Primary Outcome Measures

Name	Time	Method
miRNome analysis	baseline	The Next Generation Sequencing (NGS) techniques will be used to identify miRNome picture as potential biomarkers for acute and chronic coronary syndrome.

Secondary Outcome Measures

Name	Time	Method
Identification of biomarkers of inflammation	baseline	Interleukin-6 and soluble ST2 levels will be assessed in plasma samples.

Trial Locations

Locations (1)

IRCCS INRCA Hospital; 🇮🇹 Ancona, Italy