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Clinical Trials/NCT00597922
NCT00597922
Completed
Not Applicable

Variation in Recovery: Role of Gender on Outcomes of Young Acute Myocardial Infarction (AMI) Patients (VIRGO)

Yale University92 sites in 1 country2,985 target enrollmentSeptember 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Myocardial Infarction
Sponsor
Yale University
Enrollment
2985
Locations
92
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Heart disease and heart attacks pose a serious health risk to young women, and women tend to experience less successful recoveries after a heart attack than men do. This study will examine various factors that may predispose women to heart attacks and to poor recovery after a heart attack. The differences between men and women in the medical care that they receive following a heart attack will also be studied.

Detailed Description

Heart disease is one of the leading causes of death in women 55 years and younger, accounting for more than 8,000 deaths each year in the United States. Approximately 40,000 young women are hospitalized each year in the United States as a result of a heart attack. Research has shown that young women who have heart attacks are twice as likely to die in the hospital as young men who have heart attacks. While there has been an increase in awareness, little research has been conducted on understanding heart disease and heart attacks in young women. Specific biologic markers involved with inflammation, metabolic abnormalities, sex hormones, and genetics may indicate a predisposition to a heart attack and poor recovery. This study will analyze the biologic, demographic, psychosocial, environmental, and behavioral factors that may contribute to premature heart disease and to poor recovery after a heart attack in women. Researchers will examine if delays in receiving medical care following a heart attack can affect recovery and health outcomes for women. Gender differences in outcomes and the quality of medical care that is received following a heart attack will also be examined. This study will enroll women and men who are hospitalized following a possible heart attack. At study entry, participants will be interviewed to collect information about symptoms, functioning, quality of life, and medical care. A medical record review will also occur. At 1 month after admission from the hospital, an interview will occur via phone and a blood sample will be collected when the participant returns to the hospital or alternatively be collected at a medical clinic convenient to the participant. Another telephone interview will occur at 12 months. Participants' blood samples will be stored for future biologic and genetic studies.

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
February 2013
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Elevated cardiac markers within 24 hours of arrival at initial or enrolling institution
  • Supporting evidence suggestive of a heart attack

Exclusion Criteria

  • Previously enrolled in the VIRGO study
  • Does not speak English or Spanish
  • Too ill to interview
  • Current prisoner

Outcomes

Primary Outcomes

Not specified

Study Sites (92)

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