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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Syndrome
• Intervention / Treatment: Other: blood sample collection

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Anna Rita Bonfigli, PhD; Phone Number: 0718003719; Email: a.bonfigli@inrca.it

Study Locations

• Italy
  • Ancona, Italy
    • Recruiting
    • IRCCS INRCA Hospital
    • Contact: Olga Protic, PhD; Email: o.protic@inrca.it
    • Principal Investigator: Gabriele Gabrielli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients affected by Acute Coronary Syndrome (ACS) and Chronic Coronary Syndrome (CCS) with clinical indications for coronary angiography, demonstrating the presence of significant coronary artery disease.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of biomarkers of inflammation	Interleukin-6 and soluble ST2 levels will be assessed in plasma samples.	baseline

Collaborators and Investigators

• Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
• Collaborators: Ministry of Health, Italy
• Investigators: Study Director: Roberto Antonicelli, MD, Irccs Inrca

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: microRNAs; Acute Coronary Syndrome; Chronic Coronary Syndrome; interleukin-6; soluble ST2
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: INRCA_009_2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No