DNA Methylation Analysis in Acute Coronary Syndrome and Atrial Fibrillation: DIANA Clinical Trial

NCT04371809 | Completed DMC

• 1 other identifier: GR-2016-02364785
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Although epigenetics has been identified as one of the most relevant pathophysiological components in the development of cardiovascular diseases, there is still considerable difficulty in finding markers of epigenetic damage useful in clinical practice. Moreover, these markers could be useful to predict the onset and severity of disease as well as to stratify stratification the prognostic risk during the follow-up. The aim of this project will be to evaluate the genome wide DNA methylation status in circulating CD4+ T cells and CD8+ T cells in patients with acute coronary syndromes (ACS), atrial fibrillation (AF) and with ACS in the presence of AF.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Atrial Fibrillation

Keywords

Epigenetics; DNA methylation

Outcome Measures

Primary Outcomes (1)

• DNA methylation status both of CD4+ and CD8+ cells

  DNA methylation profile of patients and controls will be measured both in CD4+ and CD8+ cells collected from peripheral blood by using Reduced Representation Bisulfite Sequencing (RRBS)

  6 months

Secondary Outcomes (1)

• Bioinformatics analysis to predict putative novel ACS and AF candidate genes

  3 months

Other Outcomes (1)

• Validation of gene expression

  3 months

Study Arms (4)

control subjects

Other: DNA methylome

subjects with Atrial Fibrillation

Other: DNA methylome

subjects with Acute Coronary Syndrome

Other: DNA methylome

subjects with Acute Coronary Syndrome and Atrial Fibrillation

Other: DNA methylome

Interventions

DNA methylome OTHER

Epigenomics tools combined with bioinformatic analysis to find and correlate putative useful clinical biomarkers with clinical features

control subjects; subjects with Acute Coronary Syndrome; subjects with Acute Coronary Syndrome and Atrial Fibrillation; subjects with Atrial Fibrillation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population will include 20 healthy controls admitted to electrocardiographic control without further cardiological, electrocardiographic and clinical evidence of cardiac pathologies, 20 patients with ACS, and 20 patients with ACS and 20 patients with AF and ACS.

You may qualify if:

• Patients with clinically diagnosed of AF and ACS, in particular unstable angina pectoris (UAP), acute myocardial infarction without ST elevation (NSTEMI) and acute myocardial infarction with ST elevation (STEMI), based on clinical history, symptoms, ECG, biomarkers of damage cardiac, coronary angiography, risk factors and/or other clinical tests according to the guidelines for UAP/ NSTEMI and STEMI

You may not qualify if:

• Patients with known history of cancer, malignancy disorders, active infections, and chronic or immune-mediated diseases.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania Luigi Vanvitelli, Cardarelli Hospital

Naples, 80138, Italy

Location

Related Publications (2)

• Infante T, Franzese M, Ruocco A, Schiano C, Affinito O, Pane K, Memoli D, Rizzo F, Weisz A, Bontempo P, Grimaldi V, Berrino L, Soricelli A, Mauro C, Napoli C. ABCA1, TCF7, NFATC1, PRKCZ, and PDGFA DNA methylation as potential epigenetic-sensitive targets in acute coronary syndrome via network analysis. Epigenetics. 2022 May;17(5):547-563. doi: 10.1080/15592294.2021.1939481. Epub 2021 Jun 21.

  PMID: 34151742 RESULT

• Schiano C, Balbi C, Burrello J, Ruocco A, Infante T, Fiorito C, Panella S, Barile L, Mauro C, Vassalli G, Napoli C. De novo DNA methylation induced by circulating extracellular vesicles from acute coronary syndrome patients. Atherosclerosis. 2022 Aug;354:41-52. doi: 10.1016/j.atherosclerosis.2022.06.1026. Epub 2022 Jul 6.

  PMID: 35830762 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Genomic DNA extracted from CD4+ and CD8+ T cells

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Atrial Fibrillation

Interventions

Epigenome

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genome; Genetic Structures; Genetic Phenomena

Study Officials

• Teresa Infante, Biol.D. Msc.

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: March 20, 2019
• Primary Completion: March 1, 2022
• Study Completion: March 20, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)