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Examining Heart Attacks in Young Women (VIRGO)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00597922
First received: January 9, 2008
Last updated: June 26, 2014
Last verified: June 2014
  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)

Resource links provided by NLM:


Further study details as provided by Yale University:

Biospecimen Retention:   Samples With DNA

Blood specimens for biomarker analysis and storage for future genetic studies


Enrollment: 2985
Study Start Date: September 2007
Study Completion Date: February 2013
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597922

  Show 92 Study Locations
Sponsors and Collaborators
Yale University
Investigators
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: June 26, 2014
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
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014