Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497478
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-05
Brief Title:
Evolutionary Aspects of Polydistrict Atherosclerosis
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Evolutionary Aspects of Polydistrict Atherosclerosis EAP Analysis and Correlation of Functional Biomolecular and Genetic Factors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
EAP
Brief Summary:
Atherosclerosis is a systemic multifocal disease that represents the leading cause of death in Western countries The risk factors contributing to its distribution extent and progression in different organs ie the heart brain or limbs and different segments large and small vessels are not identical The present study analyses data the evolutionary aspects of polydistrict atherosclerosis by analysing the possible role of morphological factors biomolecular and genetic in the progression of atherosclerotic lesions and the development of major andor minor acute cardiovascular events
For this purpose will be recalled to follow-up all 320 patients already enrolled in the previous protocol of Research in the period between 1 March 2014 and 28 February 2015 at the Department of Internal Medicine Catholic University of Rome
The subjects will undergo a new clinical evaluation with particular interest to the onset of major cardiovascular events myocardial infarction stroke death for all causes and major adverse events to the lower limbs critical ischemia of the lower limbs requiring revascularization or amputation in the follow-up period and a ultrasonographic examination of carotid arteries and arteries of lower limb districts at the Service of Angiology Catholic University of Rome
The study employed a new semiquantitative ultrasonographic score ultrasonographic lower limb atherosclerosis ULLA score that enables a complete evaluation of the entire lower limb atherosclerotic burden and has already been shown to be associated with major cardiovascular risk factors
Therefore the aims of this study are
to assess the association between functional morphological biomolecular and genetic factors of atherosclerotic disease and the risk of major cardiovascular events MACE and major adverse events to the lower limbs MALE
to analyse the morphological progression of atherosclerotic disease in its different localizations and the possible determining factors in such progression with a 10-year follow-up ultrasound study
For this purpose will be recalled to follow-up all 320 patients already enrolled in the previous protocol of Research in the period between 1 March 2014 and 28 February 2015 at the Department of Internal Medicine Catholic University of Rome
The subjects will undergo a new clinical evaluation with particular interest to the onset of major cardiovascular events myocardial infarction stroke death for all causes and major adverse events to the lower limbs critical ischemia of the lower limbs requiring revascularization or amputation in the follow-up period and a ultrasonographic examination of carotid arteries and arteries of lower limb districts at the Service of Angiology Catholic University of Rome
The study employed a new semiquantitative ultrasonographic score ultrasonographic lower limb atherosclerosis ULLA score that enables a complete evaluation of the entire lower limb atherosclerotic burden and has already been shown to be associated with major cardiovascular risk factors
Therefore the aims of this study are
to assess the association between functional morphological biomolecular and genetic factors of atherosclerotic disease and the risk of major cardiovascular events MACE and major adverse events to the lower limbs MALE
to analyse the morphological progression of atherosclerotic disease in its different localizations and the possible determining factors in such progression with a 10-year follow-up ultrasound study
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