Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) of Women With Acute Coronary Syndrome

Not yet recruiting

• Conditions: Gender; Acute Coronary Syndrome; Genetic Predisposition

• Registration Number: NCT06441942
• Lead Sponsor: IRCCS San Raffaele

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.

Study Timeline

• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-05-29
• Status Verified: 2024-06
• Study First Posted: 2024-06-04
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Study Start: 2024-09-01
• Primary Completion: 2025-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multicentric Registry	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

Trial Locations

Locations (1)

IRCCS San Raffaele Hospital; 🇮🇹 Milano, Italy Milan, Italy