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

March 30, 2026 updated by: Chieffo Alaide, IRCCS San Raffaele

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Italy Milan
      • Milan, Italy Milan, Italy, 20132
        • Recruiting
        • IRCCS San Raffaele Hospital
        • Contact:
        • Contact:
    • Milan
      • Milan, Milan, Italy, 20122
    • Milano
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will include female patients presenting with ACS (according to ESC guidelines)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Case
Female patient presenting with ACS (age >/= 18)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Collaborators

Federico II University
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Centro Cardiologico Monzino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2025

Primary Completion (Actual)

February 28, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

May 29, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNRR-MCNT2-2023-12377431

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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