ClinicalTrials.gg
RecruitingNCT06441942ACS GEDIUpdated Apr 3, 2026

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

An observational study in Acute Coronary Syndrome, Gender and Genetic Predisposition, sponsored by IRCCS San Raffaele. Recruiting at 4 sites in Italy. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by IRCCS San Raffaele · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 9 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 100 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 138 studies in Acute Coronary Syndrome with a site in Italy — 25 open to participants now, 30 under way, 2 of them phase 3. Acute Coronary Syndrome · Italy.

Planned enrollment
45th of 52
100 · median 1,000
Started
2025
with 6 others
Observational
53 of 138
13 open now
Primary completion
2026-02
later than 9 of 29 live
Registered
121st of 138
by date

Among the 138 studies in Acute Coronary Syndrome with a site in Italy, this one is the 45th largest by planned enrollment of the 52 observational ones that give a count, is one of 7 that started in 2025, is one of 53 observational ones, reaches primary completion later than 9 of the 29 other live ones, and was the 121st registered.

Acute Coronary Syndrome

1,489 studies on the registry are indexed under Acute Coronary Syndrome; 271 are open to participants now.

Browse Acute Coronary Syndrome studies →

Open to participants now

25 of the 138 studies in Acute Coronary Syndrome with a site in Italy are open now. Recruiting first, the newest first:

19 more — sign in →

All 25 open studies →

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 195 Acute Coronary Syndrome studies recruiting now, 144 (74%) set no upper age limit and 19 (10%) stop at 75 or younger; 14 take children under 18; 15 take healthy volunteers.

This study: 18 Years to 100 Years · female · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 138 studies in Acute Coronary Syndrome with a site in Italy, or all of them as a file.
02

Study 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.

Read the 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:

  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.
03

Conditions studied

  • Acute Coronary Syndrome
  • Gender
  • Genetic Predisposition

Keywords

  • ACS
  • GEDI
  • Genetic
  • DNA
  • mRNA
  • Proteomic
  • Metabolomic
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • age \< 18 years and/or unwillingness to sign and/or unwillingness to make follow-up visits
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Case

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

06

What researchers measure

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

    Time frame: 12 months of follow-up

07

Study locations

4 of 4 sites recruiting
08

References and documents

Publications

  • Weiss AM. Cardiovascular disease in women. Prim Care. 2009 Mar;36(1):73-102, viii. doi: 10.1016/j.pop.2008.10.012. PubMed 19231603 ↗
  • 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. PubMed 34010613 ↗
  • Graham G. Acute Coronary Syndromes in Women: Recent Treatment Trends and Outcomes. Clin Med Insights Cardiol. 2016 Feb 8;10:1-10. doi: 10.4137/CMC.S37145. eCollection 2016. PubMed 26884685 ↗
  • Vaccarino V, Parsons L, Every NR, Barron HV, Krumholz HM. Sex-based differences in early mortality after myocardial infarction. National Registry of Myocardial Infarction 2 Participants. N Engl J Med. 1999 Jul 22;341(4):217-25. doi: 10.1056/NEJM199907223410401. PubMed 10413733 ↗
  • Udell JA, Fonarow GC, Maddox TM, Cannon CP, Frank Peacock W, Laskey WK, Grau-Sepulveda MV, Smith EE, Hernandez AF, Peterson ED, Bhatt DL; Get With The Guidelines Steering Committee and Investigators. Sustained sex-based treatment differences in acute coronary syndrome care: Insights from the American Heart Association Get With The Guidelines Coronary Artery Disease Registry. Clin Cardiol. 2018 Jun;41(6):758-768. doi: 10.1002/clc.22938. Epub 2018 May 11. PubMed 29521450 ↗
  • Bavishi C, Bangalore S, Patel D, Chatterjee S, Trivedi V, Tamis-Holland JE. Short and long-term mortality in women and men undergoing primary angioplasty: A comprehensive meta-analysis. Int J Cardiol. 2015 Nov 1;198:123-30. doi: 10.1016/j.ijcard.2015.07.001. Epub 2015 Jul 4. PubMed 26163903 ↗
  • Renda G, Patti G, Lang IM, Siller-Matula JM, Hylek EM, Ambrosio G, Haas S, De Caterina R; Working Group on Thrombosis of the Italian Society of Cardiology. Thrombotic and hemorrhagic burden in women: Gender-related issues in the response to antithrombotic therapies. Int J Cardiol. 2019 Jul 1;286:198-207. doi: 10.1016/j.ijcard.2019.02.004. Epub 2019 Feb 8. PubMed 30777407 ↗
  • Smilowitz NR, Mahajan AM, Roe MT, Hellkamp AS, Chiswell K, Gulati M, Reynolds HR. Mortality of Myocardial Infarction by Sex, Age, and Obstructive Coronary Artery Disease Status in the ACTION Registry-GWTG (Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines). Circ Cardiovasc Qual Outcomes. 2017 Dec;10(12):e003443. doi: 10.1161/CIRCOUTCOMES.116.003443. PubMed 29246884 ↗
  • Wechkunanukul K, Grantham H, Damarell R, Clark RA. The association between ethnicity and delay in seeking medical care for chest pain: a systematic review. JBI Database System Rev Implement Rep. 2016 Jul;14(7):208-35. doi: 10.11124/JBISRIR-2016-003012. PubMed 27532797 ↗
  • Bonaccorsi G, Grazzini M, Pieri L, Santomauro F, Ciancio M, Lorini C. Assessment of Health Literacy and validation of single-item literacy screener (SILS) in a sample of Italian people. Ann Ist Super Sanita. 2017 Jul-Sep;53(3):205-212. doi: 10.4415/ANN_17_03_05. PubMed 28956799 ↗
  • Parker RM, Baker DW, Williams MV, Nurss JR. The test of functional health literacy in adults: a new instrument for measuring patients' literacy skills. J Gen Intern Med. 1995 Oct;10(10):537-41. doi: 10.1007/BF02640361. PubMed 8576769 ↗
  • Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available. PubMed 37622654 ↗
  • Agewall S, Beltrame JF, Reynolds HR, Niessner A, Rosano G, Caforio AL, De Caterina R, Zimarino M, Roffi M, Kjeldsen K, Atar D, Kaski JC, Sechtem U, Tornvall P; WG on Cardiovascular Pharmacotherapy. ESC working group position paper on myocardial infarction with non-obstructive coronary arteries. Eur Heart J. 2017 Jan 14;38(3):143-153. doi: 10.1093/eurheartj/ehw149. No abstract available. PubMed 28158518 ↗
  • Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available. PubMed 32860058 ↗
  • Sousa-Uva M, Neumann FJ, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur J Cardiothorac Surg. 2019 Jan 1;55(1):4-90. doi: 10.1093/ejcts/ezy289. No abstract available. PubMed 30165632 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2025 to primary completion in Feb 2026, 13 months.

Of 243 non-industry observational studies under Acute Coronary Syndrome, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's 13 months is below that.

Counting every sponsor, half of 277 studies reached it within 35 months; a quarter within 18 and three quarters within 68.

How these figures are worked out, and which studies are left out of them.

Registered
May 29, 2024
First posted
Jun 4, 2024
StartActual
Jan 28, 2025
Primary completionActual
Feb 28, 2026
CompletionEst.
Feb 28, 2027
Last update
Apr 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06441942
Lead sponsor
IRCCS San Raffaele
Responsible party
Chieffo Alaide (Prof. M.D., IRCCS San Raffaele) — Principal investigator
First posted
Jun 4, 2024
Start date
Jan 28, 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2027 (estimated)
Last update
Apr 3, 2026

Study contacts

Alaide Chieffo, MD
Contact
chieffo.alaide@hsr.it
+39/02/2643.7331 ext. 7362
Vega Rusconi
Contact
rusconi.vega@hsr.it
0226439327

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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