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Examining Heart Attacks in Young Women (VIRGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00597922
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Yale University

Study Description
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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.

Condition or disease
Acute Myocardial Infarction

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.

Study Design
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Study Type : Observational
Actual Enrollment : 2985 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Biospecimen Retention:   Samples With DNA
Blood specimens for biomarker analysis and storage for future genetic studies

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
2,000 women and 1,000 men between the ages of 18 and 55 years who are hospitalized with a heart attack
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Yale University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Harlan M. Krumholz, MD, SM Yale University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00597922    
Other Study ID Numbers: 0507000374
R01HL081153-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: June 2014
Keywords provided by Yale University:
Acute Myocardial Infarction
Heart Attack
Gender Differences
Risk Factors
Quality of Care
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases