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NCT Number: NCT06441942

Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) of Women With 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.

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Key information

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS San Raffaele Hospital, Milan, Italy Milan, Italy

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About this study

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:

  • To create a multicenter prospective registry including women with ACS from a variety of cultural and ethnical backgrounds in different Italian regions
  • 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.
  • To assess socioeconomic status, health literacy and awareness of risk factors among enrolled patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Alaide Chieffo, MD

CONTACT

[email protected]

+39/02/2643.7331 ext. 7362

Vega Rusconi

CONTACT

[email protected]

0226439327

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ACS GEDI

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 4, 2024
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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