Clinical trial NCT00597922: Examining Heart Attacks in Young Women
Official title: Variation in Recovery: Role of Gender on Outcomes of Young Acute Myocardial Infarction (AMI) Patients (VIRGO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
Heart Attack
Gender Differences
Risk Factors
Quality of Care
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-01-18
Enrollment: 2985
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: Providence Hospital
state: Alabama
city: La Mesa
country: United States
facility: Sharp Gross Hospital
state: California
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center/PRCC Cardiology Research
state: California
city: Modesto
country: United States
facility: Memorial Medical Center (Sutter Gould Medical Foundation)
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center Sacramento
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: San Francisco
country: United States
facility: California Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Stockton
country: United States
facility: St Joseph's Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Hospital and Medical Center
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Denver
country: United States
facility: Centura Research Center
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Hartford
country: United States
facility: St Francis Hospital and Medical Center
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: New Haven
country: United States
facility: Hospital of St. Raphael
state: Connecticut
city: Inverness
country: United States
facility: Citrus Memorial Health Systems
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac & Vascular Institute, Baptist Hospital of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Tampa
country: United States
facility: Pepin Heart Research Institute
state: Florida
city: Belleville
country: United States
facility: St Elizabeth's Hospital
state: Illinois
city: Chicago
country: United States
facility: Mercy Hospital and Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Evanston
country: United States
facility: Northshore University Health System
state: Illinois
city: Springfield
country: United States
facility: Memorial Health System
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Krannert Heart Institute - Indiana University - Clarian Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: The Indiana Heart Hospital
state: Indiana
city: Indianapolis
country: United States
facility: St Vincent Hospital & Health Services
state: Indiana
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center
state: Kansas
city: Baton Rouge
country: United States
facility: Cardiovascular Research Foundation of Louisiana
state: Louisiana
city: Lewiston
country: United States
facility: Central Maine Heart and Vascular Institute
state: Maine
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Dearborn
country: United States
facility: Oakwood Hospital and Medical Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: St John Hospital & Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Lansing
country: United States
facility: Sparrow Hospital
state: Michigan
city: Mount Clemens
country: United States
facility: Mount Clemens Regional Medical Center
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Joplin
country: United States
facility: St John's Regional Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Mid-America Heart Institute, St Luke's Hospital
state: Missouri
city: Saint Joseph
country: United States
facility: Heartland Cardiovascular Consultants
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Springfield
country: United States
facility: Cox South Hospital
state: Missouri
city: Springfield
country: United States
facility: St John's Medical Research Institute
state: Missouri
city: Bozeman
country: United States
facility: Bozeman Deaconess Hospital
state: Montana
city: Kalispell
country: United States
facility: Glacier View Cardiology
state: Montana
city: Missoula
country: United States
facility: The International Heart Institute of Montana
state: Montana
city: Kearney
country: United States
facility: Good Samaritan Hospital
state: Nebraska
city: Lincoln
country: United States
facility: BryanLGH Heart Institute
state: Nebraska
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Summit
country: United States
facility: Overlook Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Heart Group
state: New Mexico
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore/Albert Einstein Medical Center
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Hospital - Mid Carolina Cardiology
state: North Carolina
city: Charlotte
country: United States
facility: Presbysterian Hospital - Mid Carolina Cardiology
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Akron
country: United States
facility: Summa Health System (Akron City Hospital)
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Lima
country: United States
facility: St Rita's Medical Center
state: Ohio
city: Bend
country: United States
facility: Heart Institute of the Cascades
state: Oregon
city: Corvallis
country: United States
facility: Samaritan Heart & Vascular Institute
state: Oregon
city: Butler
country: United States
facility: Butler Memorial Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Clinic - Cardiology
state: Pennsylvania
city: Erie
country: United States
facility: Hamot Medical Center
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Sayre
country: United States
facility: D. Guthrie Foundation for Education & Research
state: Pennsylvania
city: Sharon
country: United States
facility: Sharon Regional Health System
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas (UTSW)
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Norfolk
country: United States
facility: Sentara Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Huntington
country: United States
facility: St Mary's Medical Center
state: West Virginia
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital
state: Wisconsin
Study officials:
affiliation: Yale University
name: Harlan M. Krumholz, MD, SM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ding Q, Spatz ES, Lipska KJ, Lin H, Spertus JA, Dreyer RP, Whittemore R, Funk M, Bueno H, Krumholz HM. Newly diagnosed diabetes and outcomes after acute myocardial infarction in young adults. Heart. 2021 Apr;107(8):657-666. doi: 10.1136/heartjnl-2020-317101. Epub 2020 Oct 20.
citation: Ding Q, Funk M, Spatz ES, Whittemore R, Lin H, Lipska KJ, Dreyer RP, Spertus JA, Krumholz HM. Association of Diabetes Mellitus With Health Status Outcomes in Young Women and Men After Acute Myocardial Infarction: Results From the VIRGO Study. J Am Heart Assoc. 2019 Sep 3;8(17):e010988. doi: 10.1161/JAHA.118.010988. Epub 2019 Aug 23.
citation: Khera AV, Chaffin M, Zekavat SM, Collins RL, Roselli C, Natarajan P, Lichtman JH, D'Onofrio G, Mattera J, Dreyer R, Spertus JA, Taylor KD, Psaty BM, Rich SS, Post W, Gupta N, Gabriel S, Lander E, Ida Chen YD, Talkowski ME, Rotter JI, Krumholz HM, Kathiresan S. Whole-Genome Sequencing to Characterize Monogenic and Polygenic Contributions in Patients Hospitalized With Early-Onset Myocardial Infarction. Circulation. 2019 Mar 26;139(13):1593-1602. doi: 10.1161/CIRCULATIONAHA.118.035658.
citation: Safdar B, Spatz ES, Dreyer RP, Beltrame JF, Lichtman JH, Spertus JA, Reynolds HR, Geda M, Bueno H, Dziura JD, Krumholz HM, D'Onofrio G. Presentation, Clinical Profile, and Prognosis of Young Patients With Myocardial Infarction With Nonobstructive Coronary Arteries (MINOCA): Results From the VIRGO Study. J Am Heart Assoc. 2018 Jun 28;7(13):e009174. doi: 10.1161/JAHA.118.009174.
citation: Lu Y, Ding Q, Xu X, Spatz ES, Dreyer RP, D'Onofrio G, Caulfield M, Nasir K, Spertus JA, Krumholz HM. Sex Differences in Omega-3 and -6 Fatty Acids and Health Status Among Young Adults With Acute Myocardial Infarction: Results From the VIRGO Study. J Am Heart Assoc. 2018 May 30;7(11):e008189. doi: 10.1161/JAHA.117.008189.
citation: Lu Y, Zhou S, Dreyer RP, Spatz ES, Geda M, Lorenze NP, D'Onofrio G, Lichtman JH, Spertus JA, Ridker PM, Krumholz HM. Sex Differences in Inflammatory Markers and Health Status Among Young Adults With Acute Myocardial Infarction: Results From the VIRGO (Variation in Recovery: Role of Gender on Outcomes of Young Acute Myocardial Infarction Patients) Study. Circ Cardiovasc Qual Outcomes. 2017 Feb;10(2):e003470. doi: 10.1161/CIRCOUTCOMES.116.003470. Epub 2017 Feb 22.
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