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

Sponsor

Istituto Nazionale di Ricovero e Cura per Anziani (Other)

Overall Status

Recruiting

CT.gov ID

NCT06103357

Collaborator

Ministry of Health, Italy (Other)

Enrollment

Location

9.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Syndrome	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 Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Mar 6, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Identification of biomarkers of inflammation [baseline]
Interleukin-6 and soluble ST2 levels will be assessed in plasma samples.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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)