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

Coronary Syndrome Clinical Trial

— PLAQUE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06103357
• Other study ID #: INRCA_009_2023
• Status: Recruiting
• Start date: March 6, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: October 2023
• Source: Istituto Nazionale di Ricovero e Cura per Anziani
• Contact: Anna Rita Bonfigli, PhD
• Phone: 0718003719
• Email: a.bonfigli[@]inrca.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS INRCA Hospital	Ancona

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani	Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Identification of biomarkers of inflammation	Interleukin-6 and soluble ST2 levels will be assessed in plasma samples.	baseline