Prospective Multicenter Registry of Gender, Diversity and... | NCT06441942

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

NCT06441942

Sponsor

IRCCS San Raffaele

Status

Recruiting

Last Update Posted

Apr 3, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Acute Coronary Syndrome
Gender
Genetic Predisposition

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 28, 2025Actual

Primary Completion Date

Feb 28, 2026Actual

Completion Date

Feb 28, 2027Estimated

First Submitted Date

May 29, 2024

First Submission Date that Met QC Criteria

May 29, 2024

First Posted Date

Jun 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2026

Last Update Posted Date

Apr 3, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chieffo Alaide, Prof. M.D., IRCCS San RaffaelePrincipal Investigator

Lead Sponsor

IRCCS San RaffaeleOTHER

Collaborators

Name	Class
Federico II University	OTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	OTHER
Centro Cardiologico Monzino	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Case		Female patient presenting with ACS (age >/= 18)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female patient >/= 18

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alaide Chieffo, MD	Contact	+39/02/2643.7331	7362	chieffo.alaide@hsr.it
Vega Rusconi	Contact	0226439327		rusconi.vega@hsr.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS San Raffaele Hospital	Recruiting	Milan	Italy Milan	20132	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19231603	Background	Weiss AM. Cardiovascular disease in women. Prim Care. 2009 Mar;36(1):73-102, viii. doi: 10.1016/j.pop.2008.10.012.
34010613	Background	Vogel B, Acevedo M, Appelman Y, Bairey Merz CN, Chieffo A, Figtree GA, Guerrero M, Kunadian V, Lam CSP, Maas AHEM, Mihailidou AS, Olszanecka A, Poole JE, Saldarriaga C, Saw J, Zuhlke L, Mehran R. The Lancet women and cardiovascular disease Commission: reducing the global burden by 2030. Lancet. 2021 Jun 19;397(10292):2385-2438. doi: 10.1016/S0140-6736(21)00684-X. Epub 2021 May 16.

ID	Term
D054058	Acute Coronary Syndrome
D003075	Coitus
D020022	Genetic Predisposition to Disease

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases