Registry of genetic, molecular, and diversity differences in 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.
Run by IRCCS San Raffaele · NCT06441942 · Data updated 2026-11-12
This project will collect clinical, genetic, biochemical, and molecular information from women with acute coronary syndrome across Italy to see if differences by age, ethnicity, or disease type relate to presentation and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 4 sites (Milan, Italy Milan and 3 other locations) |
| Status | Recruiting |
| Started | January 28, 2025 |
| Main results expected | February 28, 2026 |
| Study ends | February 28, 2027 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT06441942 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 years or older diagnosed with acute coronary syndrome (STEMI, NSTEMI, or unstable angina) who can give informed consent and attend follow-up visits are ideal candidates.
✕Probably not a fit
Men, people under 18, and women unwilling to consent or unable to attend follow-up visits are not eligible and therefore will not benefit from participation in this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective multicenter registry enrolling women (≥18 years) with acute coronary syndrome (STEMI, NSTEMI, or unstable angina) at several Italian cardiovascular centers. Participants will undergo detailed clinical, imaging, genetic (DNA/mRNA), biochemical, and molecular profiling, with data stratified by age and by obstructive versus non-obstructive coronary artery disease. The protocol also captures socioeconomic status, health literacy, and awareness of risk factors to explore social determinants of disease. Collected data will be analyzed to identify disease subtypes and biological or demographic patterns that may influence management and outcomes.
Why it matters
Potential benefit: If successful, the registry could help personalize diagnosis and treatment for women with ACS by identifying biological and social subtypes linked to different outcomes.
How similar studies have gone: Previous registries and research have documented sex-related differences in ACS and identified some genetic associations, but combining broad molecular profiling with explicit diversity-focused sampling across regions is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
IRCCS San Raffaele Hospital
Milan, Italy Milan, Italy Recruiting -
Centro Cardiologico Monzino
Milan, Milano, Italy Recruiting -
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Milan, Italy Recruiting -
Azienda Ospedaliera Universitaria Federico II
Naples, Napoli, Italy Recruiting
Study contacts
- Study coordinator: Alaide Chieffo, MD
- Email: chieffo.alaide@hsr.it
- Phone: +39/02/2643.7331
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.