Examining Heart Attacks in Young Women (VIRGO)
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|ClinicalTrials.gov Identifier: NCT00597922|
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : June 30, 2014
|Condition or disease|
|Acute Myocardial Infarction|
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.
|Study Type :||Observational|
|Actual Enrollment :||2985 participants|
|Official Title:||Variation in Recovery: Role of Gender on Outcomes of Young Acute Myocardial Infarction (AMI) Patients (VIRGO)|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
2,000 women between the ages of 18 and 55 years who are hospitalized with a heart attack
1,000 men between the ages of 18 and 55 years who are hospitalized with a heart attack
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597922
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|Principal Investigator:||Harlan M. Krumholz, MD, SM||Yale University|