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

NCT06441942 | Not Yet Recruiting DMC

• 1 other identifier: PNRR-MCNT2-2023-12377431
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Gender; Genetic Predisposition

Keywords

ACS; GEDI; Genetic; DNA; mRNA; Proteomic; Metabolomic

Outcome Measures

Primary Outcomes (1)

• Multicentric Registry

  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

Study Arms (1)

Case

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Female patient \>/= 18
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Women \>/= 18 years with ACS (STEMI, NSTEMI or Unstable Angina).

You may not qualify if:

• age \< 18 years and/or unwillingness to sign informed consent and/or unwillingness to make follow-up visits

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Federico II University: collaborator

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, Italy Milan, 20132, Italy

Location

Related Publications (15)

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Related Links

• Related Info
• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

DNA, mRNA, proteomic and metabolomic.

MeSH Terms

Conditions

Acute Coronary Syndrome; Coitus; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Sexual Behavior; Behavior; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alaide Chieffo, MD

CONTACT

+39/02/2643.7331; chieffo.alaide@hsr.it

Vega Rusconi

CONTACT

0226439327; rusconi.vega@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. M.D.

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: September 1, 2024
• Primary Completion: July 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

IT (1)