Ignite Creation Date:
2024-05-06 @ 2:38 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04371809
Status:
COMPLETED
Last Update Posted:
2022-07-19
First Post:
2020-04-29
Brief Title:
DNA Methylation Analysis in Acute Coronary Syndrome and Atrial Fibrillation DIANA Clinical Trial
Sponsor:
University of Campania Luigi Vanvitelli
Organization:
University of Campania Luigi Vanvitelli
Study Overview
Official Title:
DNA Methylation Analysis to Identify Functional Epigenetic Marks in Acute Coronary Syndrome and Atrial Fibrillation DIANA Clinical Trial
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 40 patients with ACS affected or not by AF recruited at the UTIC of the UOC of Cardiology at the AORN A Cardarelli Naples Italy Director of the UOC Dr Ciro Mauro as Head of Unit of the study at AORN Cardarelli assisted by Dr Antonio Ruocco Medical Director of Cardiology
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 andor other clinical tests according to the guidelines for UAP NSTEMI and STEMI will be recruited at the UTIC of the AORN A Cardarelli Naples Italy All recruited subjects will sign a written informed consent for a blood sampling for non-profit research purposes Pharmacological therapy diagnostic information and clinical examination data and medical history will be collected from medical records Blood samples will be collected during normal clinical practice without taking additional samples from the first day of admission before the use of drugs such as heparin and contrast agents 90 of the samples will be collected within a day of acute event Patients with primary cardiomyopathies congenital heart disease valvular diseases stroke diabetes mellitus autoimmune diseases acute infections chronic lung infections COPD emphysema pneumoconiosis asthma chronic bronchitis tuberculosis pleurisy chronic liver disease and kidney disease hyperthyroidism or subjects whom will claim an acute febrile illness within 2 weeks will be excluded from the study
The collection of whole blood will be carried out from patients and controls during the normal clinical practice Biological samples will be immediately processed and stored at 4 C at the regional reference biobank of the UOC of Clinical Immunology and Immunohematology Transfusion Medicine and Transplantation Immunology with annexed Single Regional Reference Laboratory for Organ Transplant Immunology LIT at the Department of Internal Medicine at the University of Campania Luigi Vanvitelli Naples Italy
A total of 25 mL of peripheral venous blood will be collected in EDTA tubes and usually processed within 1 hour Peripheral blood mononuclear cells PBMNCs will be isolated by Ficoll gradient using Histopaque-1077 Sigma-Aldrich according to manufacturers instructions
CD4 and CD8 T lymphocytes will be purified from PBMCs using EasySep Human CD4 T and Cell Isolation Kit and EasySep Human CD4 T Cell Isolation Kit STEMCELL Technologies starting by 5x107mL of PBMNCs respectively
Genomic DNA of purified lymphocite subset from each study participant will be isolated immediately after cell isolation using DNeasy Blood Tissue Kit Qiagen according to manufacturers protocol DNA concentration and purity will be determined by using NanoDrop spectrophotometer ND-2000 Thermo Scientific through the evaluation of the absorbance ratio A260A280 and DNA integrity checked on 1 agarose gel
RRB Sequencing and bioinformatic analyses will be performed by an external Service
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 andor other clinical tests according to the guidelines for UAP NSTEMI and STEMI will be recruited at the UTIC of the AORN A Cardarelli Naples Italy All recruited subjects will sign a written informed consent for a blood sampling for non-profit research purposes Pharmacological therapy diagnostic information and clinical examination data and medical history will be collected from medical records Blood samples will be collected during normal clinical practice without taking additional samples from the first day of admission before the use of drugs such as heparin and contrast agents 90 of the samples will be collected within a day of acute event Patients with primary cardiomyopathies congenital heart disease valvular diseases stroke diabetes mellitus autoimmune diseases acute infections chronic lung infections COPD emphysema pneumoconiosis asthma chronic bronchitis tuberculosis pleurisy chronic liver disease and kidney disease hyperthyroidism or subjects whom will claim an acute febrile illness within 2 weeks will be excluded from the study
The collection of whole blood will be carried out from patients and controls during the normal clinical practice Biological samples will be immediately processed and stored at 4 C at the regional reference biobank of the UOC of Clinical Immunology and Immunohematology Transfusion Medicine and Transplantation Immunology with annexed Single Regional Reference Laboratory for Organ Transplant Immunology LIT at the Department of Internal Medicine at the University of Campania Luigi Vanvitelli Naples Italy
A total of 25 mL of peripheral venous blood will be collected in EDTA tubes and usually processed within 1 hour Peripheral blood mononuclear cells PBMNCs will be isolated by Ficoll gradient using Histopaque-1077 Sigma-Aldrich according to manufacturers instructions
CD4 and CD8 T lymphocytes will be purified from PBMCs using EasySep Human CD4 T and Cell Isolation Kit and EasySep Human CD4 T Cell Isolation Kit STEMCELL Technologies starting by 5x107mL of PBMNCs respectively
Genomic DNA of purified lymphocite subset from each study participant will be isolated immediately after cell isolation using DNeasy Blood Tissue Kit Qiagen according to manufacturers protocol DNA concentration and purity will be determined by using NanoDrop spectrophotometer ND-2000 Thermo Scientific through the evaluation of the absorbance ratio A260A280 and DNA integrity checked on 1 agarose gel
RRB Sequencing and bioinformatic analyses will be performed by an external Service
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None