Examining Heart Attacks in Young Women

Acute Myocardial Infarction Clinical Trial

— VIRGO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597922
• Other study ID #: 0507000374
• Secondary ID: R01HL081153-01A1
• Status: Completed
• Start date: September 2007
• Est. completion date: February 2013

Study information

• Verified date: June 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2985
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United States	Summa Health System (Akron City Hospital)	Akron	Ohio
United States	Presbyterian Heart Group	Albuquerque	New Mexico
United States	Cardiovascular Research Foundation of Louisiana	Baton Rouge	Louisiana
United States	St Elizabeth's Hospital	Belleville	Illinois
United States	Heart Institute of the Cascades	Bend	Oregon
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Jacobi Medical Center	Bronx	New York
United States	Montefiore/Albert Einstein Medical Center	Bronx	New York
United States	Erie County Medical Center	Buffalo	New York
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Butler Memorial Hospital	Butler	Pennsylvania
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Presbysterian Hospital - Mid Carolina Cardiology	Charlotte	North Carolina
United States	Presbyterian Hospital - Mid Carolina Cardiology	Charlotte	North Carolina
United States	Mercy Hospital and Medical Center	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Samaritan Heart & Vascular Institute	Corvallis	Oregon
United States	Baylor Research Institute	Dallas	Texas
United States	University of Texas Southwestern Medical Center at Dallas (UTSW)	Dallas	Texas
United States	Geisinger Clinic - Cardiology	Danville	Pennsylvania
United States	Genesis Medical Center	Davenport	Iowa
United States	Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Centura Research Center	Denver	Colorado
United States	Denver Health Medical Center	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	St John Hospital & Medical Center	Detroit	Michigan
United States	Hamot Medical Center	Erie	Pennsylvania
United States	Northshore University Health System	Evanston	Illinois
United States	Parkview Hospital	Fort Wayne	Indiana
United States	Spectrum Health	Grand Rapids	Michigan
United States	Pinnacle Health System	Harrisburg	Pennsylvania
United States	St Francis Hospital and Medical Center	Hartford	Connecticut
United States	St Mary's Medical Center	Huntington	West Virginia
United States	Krannert Heart Institute - Indiana University - Clarian Methodist Hospital	Indianapolis	Indiana
United States	St Vincent Hospital & Health Services	Indianapolis	Indiana
United States	The Indiana Heart Hospital	Indianapolis	Indiana
United States	Citrus Memorial Health Systems	Inverness	Florida
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	St John's Regional Medical Center	Joplin	Missouri
United States	Glacier View Cardiology	Kalispell	Montana
United States	Mid-America Heart Institute, St Luke's Hospital	Kansas City	Missouri
United States	Good Samaritan Hospital	Kearney	Nebraska
United States	Sharp Gross Hospital	La Mesa	California
United States	Saddleback Memorial Medical Center	Laguna Hills	California
United States	Sparrow Hospital	Lansing	Michigan
United States	Central Maine Heart and Vascular Institute	Lewiston	Maine
United States	St Rita's Medical Center	Lima	Ohio
United States	BryanLGH Heart Institute	Lincoln	Nebraska
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Cedars-Sinai Medical Center/PRCC Cardiology Research	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Baptist Cardiac & Vascular Institute, Baptist Hospital of Miami	Miami	Florida
United States	Winthrop University Hospital	Mineola	New York
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	The International Heart Institute of Montana	Missoula	Montana
United States	Providence Hospital	Mobile	Alabama
United States	Memorial Medical Center (Sutter Gould Medical Foundation)	Modesto	California
United States	Mount Clemens Regional Medical Center	Mount Clemens	Michigan
United States	Hospital of St. Raphael	New Haven	Connecticut
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Sentara Hospital	Norfolk	Virginia
United States	Orlando Health	Orlando	Florida
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Virginia Commonwealth University	Richmond	Virginia
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Mercy General Hospital	Sacramento	California
United States	Sutter Medical Center Sacramento	Sacramento	California
United States	Heartland Cardiovascular Consultants	Saint Joseph	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	California Medical Center	San Francisco	California
United States	D. Guthrie Foundation for Education & Research	Sayre	Pennsylvania
United States	Sharon Regional Health System	Sharon	Pennsylvania
United States	Cox South Hospital	Springfield	Missouri
United States	Memorial Health System	Springfield	Illinois
United States	St John's Medical Research Institute	Springfield	Missouri
United States	Stanford University Medical Center	Stanford	California
United States	St Joseph's Medical Center	Stockton	California
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Overlook Hospital	Summit	New Jersey
United States	Pepin Heart Research Institute	Tampa	Florida
United States	Los Robles Hospital and Medical Center	Thousand Oaks	California
United States	Cotton-O'Neil Clinical Research Center	Topeka	Kansas
United States	Torrance Memorial Medical Center	Torrance	California
United States	Munson Medical Center	Traverse City	Michigan
United States	Waukesha Memorial Hospital	Waukesha	Wisconsin
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States,