Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441942
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-29
Brief Title:
Prospective Multicenter Registry of Gender Diversity and Inclusion GEDI of Women With Acute Coronary Syndrome
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Creation of a Prospective Multicenter Registry of Gender Diversity and Inclusion GEDI in Phenotypic and Genetic Characterization of Acute Coronary Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
ACS GEDI
Brief Summary:
Create a multicenter prospective registry that collects information from women affected by acute coronary syndrome ACS This registry aims to understand the diversity in the presentation of women with ACS It proposes to conduct a thorough characterization of the women involved in the study through genetic biochemical and molecular analysisThis approach aims to identify any differences in the characteristics of women with ACS and to identify disease subtypes that may influence treatment options and clinical outcomes
Detailed Description:
Create a multicenter prospective registry that collects information from women affected by acute coronary syndrome ACS from a wide range of cultural and ethnic backgrounds distributed across various Italian regions This registry aims to understand the diversity in the presentation of women with ACS in Italy providing valuable data for a better understanding of the disease
Additionally it proposes to conduct a thorough characterization of the women involved in the study through genetic biochemical and molecular analysis This analysis will be stratified by age and the etiology of coronary artery disease distinguishing between obstructive and non-obstructive coronary artery disease
Specific aims of this proposal are
1 To create a multicenter prospective registry including women with ACS from a variety of cultural and ethnical backgrounds in different Italian regions
2 To deeply characterize women with ACS through clinical imaging genetic biochemical and molecular phenotyping stratifying for age etiology obstructive vs non-obstructive CAD and diversity
3 To assess socioeconomic status health literacy and awareness of risk factors among enrolled patients
Additionally it proposes to conduct a thorough characterization of the women involved in the study through genetic biochemical and molecular analysis This analysis will be stratified by age and the etiology of coronary artery disease distinguishing between obstructive and non-obstructive coronary artery disease
Specific aims of this proposal are
1 To create a multicenter prospective registry including women with ACS from a variety of cultural and ethnical backgrounds in different Italian regions
2 To deeply characterize women with ACS through clinical imaging genetic biochemical and molecular phenotyping stratifying for age etiology obstructive vs non-obstructive CAD and diversity
3 To assess socioeconomic status health literacy and awareness of risk factors among enrolled patients
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