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Examining Heart Attacks in Young Women (VIRGO)

Yale University logo

Yale University

Status

Completed

Conditions

Acute Myocardial Infarction

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00597922
0507000374
R01HL081153-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,985 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

2,985 participants in 2 patient groups

1
Description:
2,000 women between the ages of 18 and 55 years who are hospitalized with a heart attack
2
Description:
1,000 men between the ages of 18 and 55 years who are hospitalized with a heart attack

Trial contacts and locations

92

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Data sourced from clinicaltrials.gov

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