Examining Heart Attacks in Young Women (VIRGO)

March 27, 2020 updated by: Yale University

Variation in Recovery: Role of Gender on Outcomes of Young Acute Myocardial Infarction (AMI) Patients (VIRGO)

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2985

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0007
        • University of Alabama at Birmingham
      • Mobile, Alabama, United States, 36685
        • Providence Hospital
    • California
      • La Mesa, California, United States, 91942
        • Sharp Gross Hospital
      • Laguna Hills, California, United States, 92653
        • Saddleback Memorial Medical Center
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center/PRCC Cardiology Research
      • Modesto, California, United States, 95355
        • Memorial Medical Center (Sutter Gould Medical Foundation)
      • Sacramento, California, United States, 95819
        • Mercy General Hospital
      • Sacramento, California, United States, 95819-3226
        • Sutter Medical Center Sacramento
      • San Francisco, California, United States, 94120
        • California Medical Center
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
      • Stockton, California, United States, 95204
        • St Joseph's Medical Center
      • Thousand Oaks, California, United States, 91360
        • Los Robles Hospital and Medical Center
      • Torrance, California, United States, 90505
        • Torrance Memorial Medical Center
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center
      • Denver, Colorado, United States, 80210
        • Centura Research Center
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
      • Hartford, Connecticut, United States, 06105
        • St Francis Hospital and Medical Center
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
      • New Haven, Connecticut, United States, 06511
        • Hospital of St. Raphael
    • Florida
      • Inverness, Florida, United States, 34452
        • Citrus Memorial Health Systems
      • Miami, Florida, United States, 33176
        • Baptist Cardiac & Vascular Institute, Baptist Hospital of Miami
      • Orlando, Florida, United States, 32806
        • Orlando Health
      • Tampa, Florida, United States, 33613
        • Pepin Heart Research Institute
    • Illinois
      • Belleville, Illinois, United States, 62220
        • St Elizabeth's Hospital
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60616
        • Mercy Hospital and Medical Center
      • Evanston, Illinois, United States, 60201
        • NorthShore University Health System
      • Springfield, Illinois, United States, 62781
        • Memorial Health System
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Parkview Hospital
      • Indianapolis, Indiana, United States, 46250
        • The Indiana Heart Hospital
      • Indianapolis, Indiana, United States, 46202
        • Krannert Heart Institute - Indiana University - Clarian Methodist Hospital
      • Indianapolis, Indiana, United States, 46260
        • St Vincent Hospital & Health Services
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Genesis Medical Center
      • Iowa City, Iowa, United States, 54424
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Topeka, Kansas, United States, 66604
        • Cotton-O'Neil Clinical Research Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Cardiovascular Research Foundation of Louisiana
    • Maine
      • Lewiston, Maine, United States, 04240
        • Central Maine Heart and Vascular Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Michigan
      • Dearborn, Michigan, United States, 48123
        • Oakwood Hospital and Medical Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48236
        • St John Hospital & Medical Center
      • Grand Rapids, Michigan, United States, 49503-2528
        • Spectrum Health
      • Lansing, Michigan, United States, 48909-7980
        • Sparrow Hospital
      • Mount Clemens, Michigan, United States, 48043
        • Mount Clemens Regional Medical Center
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute
    • Missouri
      • Joplin, Missouri, United States, 64804-1694
        • St John's Regional Medical Center
      • Kansas City, Missouri, United States, 64111
        • Mid-America Heart Institute, St Luke's Hospital
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Cardiovascular Consultants
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Springfield, Missouri, United States, 65804
        • Cox South Hospital
      • Springfield, Missouri, United States, 65807
        • St John's Medical Research Institute
    • Montana
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Hospital
      • Kalispell, Montana, United States, 59901
        • Glacier View Cardiology
      • Missoula, Montana, United States, 59802
        • The International Heart Institute of Montana
    • Nebraska
      • Kearney, Nebraska, United States, 68848
        • Good Samaritan Hospital
      • Lincoln, Nebraska, United States, 68506
        • BryanLGH Heart Institute
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
      • Summit, New Jersey, United States, 07929-0220
        • Overlook Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Presbyterian Heart Group
    • New York
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center
      • Bronx, New York, United States, 10461
        • Montefiore/Albert Einstein Medical Center
      • Buffalo, New York, United States, 14215
        • Erie County Medical Center
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • Stony Brook, New York, United States, 11794-8167
        • Stony Brook University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7075
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital - Mid Carolina Cardiology
      • Charlotte, North Carolina, United States, 78704
        • Presbysterian Hospital - Mid Carolina Cardiology
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center
    • Ohio
      • Akron, Ohio, United States, 44309
        • Summa Health System (Akron City Hospital)
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center
      • Lima, Ohio, United States, 45801
        • St Rita's Medical Center
    • Oregon
      • Bend, Oregon, United States, 97701-6015
        • Heart Institute of the Cascades
      • Corvallis, Oregon, United States, 97330
        • Samaritan Heart & Vascular Institute
    • Pennsylvania
      • Butler, Pennsylvania, United States, 16001
        • Butler Memorial Hospital
      • Danville, Pennsylvania, United States, 17822-2160
        • Geisinger Clinic - Cardiology
      • Erie, Pennsylvania, United States, 16550-0001
        • Hamot Medical Center
      • Harrisburg, Pennsylvania, United States, 17101
        • Pinnacle Health System
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Sayre, Pennsylvania, United States, 18840
        • D. Guthrie Foundation for Education & Research
      • Sharon, Pennsylvania, United States, 16146
        • Sharon Regional Health System
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Research Institute
      • Dallas, Texas, United States, 75390-9034
        • University of Texas Southwestern Medical Center at Dallas (UTSW)
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Hospital
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • West Virginia
      • Huntington, West Virginia, United States, 25702
        • St Mary's Medical Center
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • Waukesha Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Harlan M. Krumholz, MD, SM, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 9, 2008

First Submitted That Met QC Criteria

January 9, 2008

First Posted (Estimate)

January 18, 2008

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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