Prospective Multicenter Registry of Gender, Diversity & Inclusion (GEDI)

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Acute Coronary Syndrome
Gender
Genetic Predisposition
Genetic Predisposition to Disease
Syndrome

Clinical Trial Details

NCT number	NCT06441942
Study type	Observational [Patient Registry]
Source	IRCCS San Raffaele
Contact	Alaide Chieffo, MD
Phone	+39/02/2643.7331
Email	chieffo.alaide@hsr.it
Status	Not yet recruiting
Phase
Start date	September 1, 2024
Completion date	December 31, 2026

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms