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Recruiting NCT06441942

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

— Observational Acute Coronary Syndrome Gender Genetic Predisposition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Coronary Syndrome, Gender, Genetic Predisposition. Basic parameters: 18 years — 100 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • Multicentric Registry [Time frame: 12 months of follow-up]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 4 centers
  • IRCCS San Raffaele Hospital — Milan
  • Centro Cardiologico Monzino — Milan
  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico — Milan
  • Azienda Ospedaliera Universitaria Federico II — Naples

Publications

  • Weiss AM. Cardiovascular disease in women. Prim Care. 2009 Mar;36(1):73-102, viii. doi: 10.1016/j.pop.2008.10.012. PMID 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. PMID 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. PMID 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. PMID 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 PMID 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. PMID 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. PMID 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. PMID 29246884

Identifiers

NCT: NCT06441942 · PNRR-MCNT2-2023-12377431

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗