Ignite Creation Date:
2024-05-06 @ 1:16 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03974958
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2019-06-03
Brief Title:
Circulating microRNAs and Degenerative Abdominal Aorta Aneurysm
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Circulating microRNAs and Degenerative Abdominal Aorta Aneurysm Diagnostic Specificity and Prognostic Value in Clinical Practice
Status:
COMPLETED
Status Verified Date:
2023-07
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:
ACTA-miRNA
Brief Summary:
Abdominal aortic aneurysm AAA is an aortic dilatation superior or equal to 30 mm with an estimated prevalence at 8 in men over 65 year-old It evolves with no clinical signal until the rupture of the aortic wall with dramatic outcomes The pathophysiological mechanisms include extracellular matrix remodeling smooth muscle cells apoptosis aggregation and activation of inflammatory cells in the aortic wall and heredity The initiating and regulatory processes are complex and not fully elucidated They encompass local aortic environment flux thrombus wall shear stress pressure and adipose tissue and patient-dependent genetic deregulation
This project follows the previous prospective ACTA study that aimed at identifying clinical criteria circulating biomarkers or imaging data for thoracic aneurysm prognosis in an AAA population The preliminary results showed that 1 a low wall shear stress index and the luminal volume are more predictive values for a rapid AAA growth and an intraluminal thrombus than the maximal aortic diameter 2 three thoracic aortic phenotypes normal dilated aneurysmal stratify the disease extent 3 the age and the female gender are associated to an extended disease During this study we created a biobank in which blood samples of AAA patients were collected at the time of their inclusion T1 This new ACTA-miRNA study aims at correlating circulating biomarkers to the anatomical and biomechanical markers previously highlighted for a rapid aneurysmal growth Circulating miRNA are involved in parietal remodeling and constitute promising targets for estimating patients-specific aortic risk
From the literature we thus selected 18 miRNA described to be involved in AAA biology inflammation remodeling cellular homeostasis and wall shear stress As control we select non-AAA patients presenting with peripheral arterial obstructive disease PAOD matched in age BMI tobacco consumption diabetes cholesterol level and blood pressure with AAA patients enrolled in the ACTA study During their follow-up these ACTA patients are solicited to continue the program research and can participate to the ACTA-miRNA study A third time analysis is performed for them T3 we collect imaging data of total aorta required by their standard follow-up as well as a blood sample Differential analysis of the miRNA panel will be conducted between 1 AAA patients T1 vs PAOD patients 2 fast-growing AAA vs slow-growing AAA 3 AAA AAT patient group vs AAA alone andor AAA dilatation of thoracic aorta 110 patients from the ACTA study are eligible to be included into the ACTA mi-RNA study Inclusion of PAOD controls will be conducted until the number of 165 cases is reached 115 ratio
Our primary objective is to validate a circulating-miRNA signature specific for abdominal aortic aneurysm
This project follows the previous prospective ACTA study that aimed at identifying clinical criteria circulating biomarkers or imaging data for thoracic aneurysm prognosis in an AAA population The preliminary results showed that 1 a low wall shear stress index and the luminal volume are more predictive values for a rapid AAA growth and an intraluminal thrombus than the maximal aortic diameter 2 three thoracic aortic phenotypes normal dilated aneurysmal stratify the disease extent 3 the age and the female gender are associated to an extended disease During this study we created a biobank in which blood samples of AAA patients were collected at the time of their inclusion T1 This new ACTA-miRNA study aims at correlating circulating biomarkers to the anatomical and biomechanical markers previously highlighted for a rapid aneurysmal growth Circulating miRNA are involved in parietal remodeling and constitute promising targets for estimating patients-specific aortic risk
From the literature we thus selected 18 miRNA described to be involved in AAA biology inflammation remodeling cellular homeostasis and wall shear stress As control we select non-AAA patients presenting with peripheral arterial obstructive disease PAOD matched in age BMI tobacco consumption diabetes cholesterol level and blood pressure with AAA patients enrolled in the ACTA study During their follow-up these ACTA patients are solicited to continue the program research and can participate to the ACTA-miRNA study A third time analysis is performed for them T3 we collect imaging data of total aorta required by their standard follow-up as well as a blood sample Differential analysis of the miRNA panel will be conducted between 1 AAA patients T1 vs PAOD patients 2 fast-growing AAA vs slow-growing AAA 3 AAA AAT patient group vs AAA alone andor AAA dilatation of thoracic aorta 110 patients from the ACTA study are eligible to be included into the ACTA mi-RNA study Inclusion of PAOD controls will be conducted until the number of 165 cases is reached 115 ratio
Our primary objective is to validate a circulating-miRNA signature specific for abdominal aortic aneurysm
Detailed Description:
None
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