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Acute Coronary SyndromeACS GEDINCT06441942

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

An observational study of Acute Coronary Syndrome and Gender, run by IRCCS San Raffaele at 4 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years, women only
How many people
100 participants
Where
4 sitesItaly
Study dates
28 Jan 2025to 28 Feb 2027
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alaide Chieffo, MD contact

+39/02/2643.7331 ext. 7362

chieffo.alaide@hsr.it

Vega Rusconi contact

0226439327

rusconi.vega@hsr.it

Italy4 sites, 4 recruiting

  • IRCCS San Raffaele Hospital

    Milan, Italy Milan, 20132

    Alaide Chieffo, Prof. M.D., 02 26434840, chieffo.alaide@hsr.it

    Vega Rusconi, 0226439327, rusconi.vega@hsr.it

    Recruiting

  • Centro Cardiologico Monzino

    Milan, Milano, 20138

    Daniela Trabattoni, MD, Daniela.Trabattoni@cardiologicomonzino.it

    Recruiting

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    Milan, Milan, 20122

    Lucia Barbieri, MD, lucia.barbieri@policlinico.mi.it

    Recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Napoli, 80131

    Anna Franzone, MD, anna.franzone@unina.it

    Recruiting

Other trials in Italy

About this study

Official title: Creation of a Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) in Phenotypic and Genetic Characterization of Acute Coronary Syndrome.

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.
Keywords
ACS, GEDI, Genetic, DNA, mRNA, Proteomic, Metabolomic
Medical subject headings
Acute Coronary Syndrome, Coitus, Genetic Predisposition to Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06441942
Study groupRoleWhat they receive
CaseFemale patient presenting with ACS (age >/= 18)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2024
  2. Study start28 Jan 2025
  3. Primary completion28 Feb 2026
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06441942
Sponsor's protocol ID
PNRR-MCNT2-2023-12377431
Acronym
ACS GEDI
Status last verified
Mar 2026
First submitted
29 May 2024
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome and Gender, run by IRCCS San Raffaele at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alaide Chieffo, MD (+39/02/2643.7331 ext. 7362, chieffo.alaide@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Multicentric Registry (time frame: 12 months of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06441942, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

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