Clinical trial NCT06441942: Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) of Women With Acute Coronary Syndrome
Official title: Creation of a Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) in Phenotypic and Genetic Characterization of Acute Coronary Syndrome.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Coronary Syndrome
Gender
Genetic Predisposition
Keywords: ACS
GEDI
Genetic
DNA
mRNA
Proteomic
Metabolomic
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Federico II University
First posted: 2024-06-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include female patients presenting with ACS (according to ESC guidelines)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Multicentric Registry
timeFrame: 12 months of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS San Raffaele Hospital
state: Italy Milan
Study officials:
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