Clinical trial NCT06103357: Identification of Biomarkers in Subjects With Coronary Syndrome (PLAQUE Study)
Official title: Identification of Innovative Circulating and Cellular Biomarkers in Subjects With Acute and Chronic Coronary Syndrome (PLAQUE Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Syndrome
Keywords: Acute Coronary Syndrome
Chronic Coronary Syndrome
microRNAs
soluble ST2
interleukin-6
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2023-10-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: miRNome analysis
timeFrame: baseline
Secondary outcomes:
measure: Identification of biomarkers of inflammation
timeFrame: baseline
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
affiliation: IRCCS INRCA
name: Roberto Antonicelli, MD
role: STUDY_DIRECTOR
References: