NCT06103357

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

March 5, 2024

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

October 23, 2023

Last Update Submit

March 4, 2024

Conditions

Coronary Syndrome

Keywords

Acute Coronary SyndromeChronic Coronary SyndromemicroRNAssoluble ST2interleukin-6

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Identification of biomarkers of inflammation

    baseline

Study Arms (1)

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

Interventions

blood sample collectionOTHER

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.

subjects with clinical indication for coronary angioplasty

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS INRCA Hospital

Ancona, Italy

RECRUITING

Related Publications (1)

  • Protic O, Bonfigli AR, Olivieri F, Lamedica AM, Gabrielli G, Antonicelli R. miRNome profile in blood samples upstream and downstream of the coronary lesion and arterial aortic root before and after angioplasty in subjects with chronic and acute coronary syndrome: A pilot observational study protocol (Plaque study). PLoS One. 2025 Jun 13;20(6):e0324467. doi: 10.1371/journal.pone.0324467. eCollection 2025.

    PMID: 40512691DERIVED

MeSH Terms

Conditions

Angina, UnstableAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Roberto Antonicelli, MD

    IRCCS INRCA

    STUDY DIRECTOR

Central Study Contacts

Anna Rita Bonfigli, PhD

CONTACT

0718003719a.bonfigli@inrca.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 26, 2023

Study Start

March 6, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

March 5, 2024

Record last verified: 2023-10

Locations

IT(1)