Registry of genetic, molecular, and diversity differences in women with acute coronary syndrome
Creation of a Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) in Phenotypic and Genetic Characterization of Acute Coronary Syndrome.
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 4 sites (Milan, Italy Milan and 3 other locations) |
| Trial ID | NCT06441942 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan, Italy Milan and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.