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NCT06441942 Clinical Trial

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

Acute Coronary Syndrome Clinical Trial

— ACS GEDI  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06441942
Other study ID # PNRR-MCNT2-2023-12377431
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2024
Est. completion date December 31, 2026

Study information
Verified date June 2024
Source IRCCS San Raffaele
Contact Alaide Chieffo, MD
Phone +39/02/2643.7331
Email chieffo.alaide@hsr.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2026
Est. primary completion date July 31, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy IRCCS San Raffaele Hospital Milano Italy Milan

Sponsors (2)
Lead Sponsor Collaborator
IRCCS San Raffaele Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Eur Heart J. 2024 Apr 1;45(13):1145. — View Citation

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. Erratum In: Eur Heart J. 2021 May 14;42(19):1908. Eur Heart J. 2021 May 14;42(19):1925. Eur Heart J. 2021 May 13;: Eur Heart J. 2024 Feb 1;45(5):404-405. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Weiss AM. Cardiovascular disease in women. Prim Care. 2009 Mar;36(1):73-102, viii. doi: 10.1016/j.pop.2008.10.012. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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