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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06441942
Acronym
ACS GEDI
Enrollment
100
Registered
2024-06-04
Start date
2025-01-28
Completion date
2027-02-28
Last updated
2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Gender, Genetic Predisposition

Keywords

ACS, GEDI, Genetic, DNA, mRNA, Proteomic, Metabolomic

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.

Interventions

None listed

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER
Federico II University
CollaboratorOTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
CollaboratorOTHER
Centro Cardiologico Monzino
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Multicentric Registry12 months of follow-upThe aim will be to create a prospective multicenter registry of gender, diversity and inclusion (GEDI) of women with Acute Coronary Syndrome

Countries

Italy

Contacts

CONTACTAlaide Chieffo, MD
chieffo.alaide@hsr.it+39/02/2643.7331
CONTACTVega Rusconi
rusconi.vega@hsr.it0226439327

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026