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Clinical Trials/NCT06441942
NCT06441942
Not yet recruiting
Not Applicable

Creation of a Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) in Phenotypic and Genetic Characterization of Acute Coronary Syndrome.

IRCCS San Raffaele1 site in 1 country100 target enrollmentSeptember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
IRCCS San Raffaele
Enrollment
100
Locations
1
Primary Endpoint
Multicentric Registry
Status
Not yet recruiting
Last Updated
last year

Overview

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 analysis.This 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.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
December 31, 2026
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chieffo Alaide

Prof. M.D.

IRCCS San Raffaele

Eligibility Criteria

Inclusion Criteria

  • Women \>/= 18 years with ACS (STEMI, NSTEMI or Unstable Angina).

Exclusion Criteria

  • age \< 18 years and/or unwillingness to sign informed consent and/or unwillingness to make follow-up visits

Outcomes

Primary Outcomes

Multicentric Registry

Time Frame: 12 months of follow-up

The aim will be to create a prospective multicenter registry of gender, diversity and inclusion (GEDI) of women with Acute Coronary Syndrome

Study Sites (1)

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