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Variation in recovery: Role of gender on outcomes of young AMI patients (VIRGO) study design.

ABSTRACT: Among individuals with ischemic heart disease, young women with an acute myocardial infarction (AMI) represent an extreme phenotype associated with an excess mortality risk. Although women younger than 55 years of age account for less than 5% of hospitalized AMI events, almost 16 000 deaths are reported annually in this group, making heart disease a leading killer of young women. Despite a higher risk of mortality compared with similarly aged men, young women have been the subject of few studies.Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) is a large, observational study of the presentation, treatment, and outcomes of young women and men with AMI. VIRGO will enroll 2000 women, 18 to 55 years of age, with AMI and a comparison cohort of 1000 men with AMI from more than 100 participating hospitals. The aims of the study are to determine sex differences in the distribution and prognostic importance of biological, demographic, clinical, and psychosocial risk factors; to determine whether there are sex differences in the quality of care received by young AMI patients; and to determine how these factors contribute to sex differences in outcomes (including mortality, hospitalization, and health status). Blood serum and DNA for consenting participants will be stored for future studies.VIRGO will seek to identify novel and prognostic factors that contribute to outcomes in this young AMI population. Results from the study will be used to develop clinically useful risk-stratification models for young AMI patients, explain sex differences in outcomes, and identify targets for intervention.

SUBMITTER: Lichtman JH

PROVIDER: S-EPMC3064946 | biostudies-literature | 2010 Nov

REPOSITORIES: biostudies-literature

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Variation in recovery: Role of gender on outcomes of young AMI patients (VIRGO) study design.

Lichtman Judith H JH Lorenze Nancy P NP D'Onofrio Gail G Spertus John A JA Lindau Stacy T ST Morgan Thomas M TM Herrin Jeph J Bueno Héctor H Mattera Jennifer A JA Ridker Paul M PM Krumholz Harlan M HM

Circulation. Cardiovascular quality and outcomes 20101101 6

<h4>Background</h4>Among individuals with ischemic heart disease, young women with an acute myocardial infarction (AMI) represent an extreme phenotype associated with an excess mortality risk. Although women younger than 55 years of age account for less than 5% of hospitalized AMI events, almost 16 000 deaths are reported annually in this group, making heart disease a leading killer of young women. Despite a higher risk of mortality compared with similarly aged men, young women have been the sub ...[more]

PMID: 21081748

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Project description:BackgroundSome studies report that women are less likely to present with chest pain for acute myocardial infarction (AMI). Information on symptom presentation, perception of symptoms, and care-seeking behaviors is limited for young patients with AMI.MethodsWe interviewed 2009 women and 976 men aged 18 to 55 years hospitalized for AMI at 103 US hospitals participating in the VIRGO study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients). Structured patient interviews during the index AMI hospitalization were used to collect information on symptom presentation, perception of symptoms, and care-seeking behaviors. We compared patient characteristics and presentation information by sex. Multivariable hierarchical logistic regression was used to evaluate the association between sex and symptom presentation.ResultsThe majority of women (87.0%) and men (89.5%) presented with chest pain (defined as pain, pressure, tightness, or discomfort). Women were more likely to present with ≥3 associated symptoms than men (eg, epigastric symptoms, palpitations, and pain or discomfort in the jaw, neck, arms, or between the shoulder blades; 61.9% for women versus 54.8% for men, P<0.001). In adjusted analyses, women with an ST-segment-elevation AMI were more likely than men to present without chest pain (odds ratio, 1.51; 95% confidence interval, 1.03-2.22). In comparison with men, women were more likely to perceive symptoms as stress/anxiety (20.9% versus 11.8%, P<0.001) but less likely to attribute symptoms to muscle pain (15.4% versus 21.2%, P=0.029). Approximately 29.5% of women and 22.1% of men sought medical care for similar symptoms before their hospitalization (P<0.001); however, 53% of women reported that their provider did not think these symptoms were heart-related in comparison with 37% of men (P<0.001).ConclusionsThe presentation of AMI symptoms was similar for young women and men, with chest pain as the predominant symptom for both sexes. Women presented with a greater number of additional non-chest pain symptoms regardless of the presence of chest pain, and both women and their healthcare providers were less likely to attribute their prodromal symptoms to heart disease in comparison with men.

Project description:The VIRGO study is a four year research project funded by the NHLBI to study young women and men with heart attacks. A total of 2,000 women who are 18 - 55 years of age and a smaller comparison group of 1,000 similarly aged men will be enrolled in this multi-site observational study from approximately 120 different hospitals across the country. Young women have a much greater risk of dying after an acute myocardial infarction (AMI) than similarly aged men. Their mortality risk is markedly higher than that of young men, and limited data on young minority women suggest that they may have the highest risk of any young subgroup. Findings from the small number of published studies of young women with ischemic heart disease suggest that the biology, epidemiology, care, and outcomes of this group are distinct from those of men. To date, there have been no large studies of this population, even as the death toll is comparable to that from breast cancer in this country. This study will help researchers identify key factors that influence recovery from a heart attack and potentially improve the care and outcomes of young women and men with AMI. Specific Aims: To investigate the excess risk in young women with AMI and to identify key demographic, clinical, metabolic, psychosocial, health care delivery, and biological determinants of prognosis, we propose a national, prospective, observational study of 2,000 women who are 55 years or younger with AMI and a smaller comparison group of 1,000 men. Our prior work and preliminary studies indicate that the sex differences are most prominent in this age group and suggest that by 1 year after discharge, there are substantial sex differences in outcomes. We will also develop risk stratification tools that will help clinicians to identify young women with the highest and lowest risk. Specific Aim 1: Determine sex differences in outcomes following AMI. Specific Aim 2: Determine sex differences in the prevalence and prognostic importance of demographic, clinical, and psychosocial risk factors. Specific Aim 3:Determine sex differences in quality of care. Specific Aim 4: Determine sex differences in the prevalence and prognostic importance of selected biochemical biomarkers following AMI. These samples have been whole genome sequenced as part of the NHGRI's Center for Common Disease Genetics at the Broad Institute.

Project description:We assessed gender differences in pre-event health status (symptoms, functioning, quality of life) in young patients with acute myocardial infarction and whether or not this association persists following sequential adjustment for important covariates. We also evaluated the interaction between gender and prior coronary artery disease, given that aggressive symptom control is a cornerstone of care in those with known coronary disease.A total of 3501 acute myocardial infarction patients (2349 women) aged 18-55 years were enrolled from 103 US/24 Spanish hospitals (2008-2012). Clinical/health status information was obtained by medical record abstraction and patient interviews. Pre-event health status was measured by generic (Short Form-12, EuroQoL) and disease-specific (Seattle Angina Questionnaire) measures. T-test/chi-square and multivariable linear/logistic regression analysis was utilized, sequentially adjusting for covariates. Women had more co-morbidities and significantly lower generic mean health scores than men (Short Form-12 physical health = 43 ± 12 vs. 46 ± 11 and mental health = 44 ± 13 vs. 48 ± 11); EuroQoL utility index = 0.7 ± 0.2 vs. 0.8 ± 0.2 and visual analog scale = 63 ± 22 vs. 67 ± 20, P < 0.0001 for all. Their disease-specific health status was also worse, with more angina (Seattle Angina Questionnaire angina frequency = 83 ± 22 vs. 87 ± 18), worse physical function (physical limitation = 78 ± 27 vs. 87 ± 21) and poorer quality of life (55 ± 25 vs. 60 ± 22, P<0.0001 for all). In multivariable analysis, the association between female gender and worse generic physical/mental health persisted, as well as worse disease-specific physical limitation and quality of life. The interaction between gender and prior coronary artery disease was not significant in any of the health status outcomes.Young women have worse pre-event health status as compared with men, regardless of their coronary artery disease history. While future studies of gender differences should adjust for baseline health status, an opportunity may exist to better address the pre-event health status of women at risk for acute myocardial infarction.

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Variation in recovery: Role of gender on outcomes of young AMI patients (VIRGO) study design.

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Variation in recovery: Role of gender on outcomes of young AMI patients (VIRGO) study design.

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