Identification of Molecular Mechanisms of Coronary Instability in Homogeneous Subsets of Patients With Acute Coronary Syndromes for the Implementation of Precision Medicine

NCT05727982 | Unknown

• 1 other identifier: 2747
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

To further improve the outcome of ACS it is strongly needed to identify new therapeutic targets. This is possible only by improving our knowledge of the multiple molecular mechanisms leading to coronary instability through several pathways. The goal of this project is to define the molecular mechanisms responsible for the four different presentations of ACS, to identify biomarkers for their noninvasive identification and potential new therapeutic targets, thus promoting precision medicine.

Conditions

Acute Coronary Syndrome; Chronic Coronary Syndrome

Keywords

Atherosclerotic plaque; Optical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

• Identify homogeneous subsets of ACS patients at OCT interrogation of the culprit plaque

  Using Optical Coherence Tomography

  2 week

Secondary Outcomes (2)

• Assess the role of shear stress in coronary instability

  1 year

• Establish the most efficient and cost-effective biomarker panel

  1 years

Study Arms (3)

NSTEMI patients

Patients no ST-segment elevation myocardial infarction (NSTEMI)

Diagnostic Test: Venous blood samples, Biological samples analysis, Cardiology visit.

SA patients

Patients with Stable Angina (SA) diagnosis

Diagnostic Test: Venous blood samples, Biological samples analysis, Cardiology visit.

MVD patients

Patients with consecutive Mitral Valve Disease patients (MVD)

Diagnostic Test: Venous blood samples, Biological samples analysis, Cardiology visit.

Interventions

Venous blood samples, Biological samples analysis, Cardiology visit. DIAGNOSTIC_TEST

These interventions are important to study all patients recruited

MVD patients; NSTEMI patients; SA patients

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. Patients with plaque rupture and inflammation; 2. Patients with plaque rupture without inflammation; 3. Patients with intact fibrous plaque with evidence of thrombus (plaque erosion); 4. Patients with a smooth plaque.

You may qualify if:

• Men and post-menopause women of age 45-80 years; ability to understand and sign the informed consent;

You may not qualify if:

• Evidence of inflammatory or infectious diseases, malignancies, immunological or haematological disorders;
• Ejection fraction less than 40%;
• Treatment with anti-inflammatory drugs other than low-dose aspirin, and with antibiotic therapies until 1 month before the enrollment.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (2)

Fondazione Policlinico Gemelli

Roma, 00168, Italy

ACTIVE NOT RECRUITING

Fondazione Policlinico Gemelli

Roma, 00168, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool sample for the study of the composition of the intestinal bacterial flora (microbiota) faeces sample can also be collected at home, keeping it at +4°C. Such sample must be transported cold, +4°C, and delivered to the staff within 24 hours polyclinic. A venous blood sample of 18cc which will be used to evaluate: 1) the inflammatory profile systemically by measuring the following plasma biomarkers: zonulin, C-reactive protein, IL-1, IL-1Ra, IL-5, IL-6, IL-7, IL-8, IL-9, IL-12, IL-17, IFN-γ, MIP-1b, VEGF, MCP-1 and IL-8, IL-10, TNF- a, TGF-b, LPS, 2) plasma metabolites.

MeSH Terms

Conditions

Acute Coronary Syndrome; Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Giovanna GL Liuzzo

CONTACT

06/30154187; giovanna.liuzzo@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 14, 2023
• Study Start: September 13, 2019
• Primary Completion: September 5, 2023
• Study Completion: September 13, 2024
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)