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

S

San Donato Group (GSD)

Status

Not yet enrolling

Conditions

Genetic Predisposition
Acute Coronary Syndrome
Gender

Study type

Observational

Funder types

Other

Identifiers

NCT06441942
PNRR-MCNT2-2023-12377431

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Case
Description:
Female patient presenting with ACS (age \>/= 18)

Trial contacts and locations

1

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Central trial contact

Alaide Chieffo, MD; Vega Rusconi

Data sourced from clinicaltrials.gov

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