Examining Heart Attacks in Young Women (VIRGO)
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Purpose
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.
| Condition |
|---|
|
Acute Myocardial Infarction |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Variation in Recovery: Role of Gender on Outcomes of Young Acute Myocardial Infarction (AMI) Patients (VIRGO) |
Blood specimens for biomarker analysis and storage for future genetic studies
| Estimated Enrollment: | 3000 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
2,000 women between the ages of 18 and 55 years who are hospitalized with a heart attack
|
|
2
1,000 men between the ages of 18 and 55 years who are hospitalized with a heart attack
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
2,000 women and 1,000 men between the ages of 18 and 55 years who are hospitalized with a heart attack
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
Contacts and Locations
Show 92 Study Locations| Principal Investigator: | Harlan M. Krumholz, MD, SM | Yale University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00597922 History of Changes |
| Other Study ID Numbers: | 1407, R01HL081153-01A1, R01 HL081153-01A1 |
| Study First Received: | January 9, 2008 |
| Last Updated: | May 30, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Yale University:
|
Acute Myocardial Infarction Heart Attack Gender Differences Risk Factors Quality of Care |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013