NCT00597922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,985

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Geographic Reach
1 country

92 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 30, 2020

Status Verified

June 1, 2014

Enrollment Period

5.4 years

First QC Date

January 9, 2008

Last Update Submit

March 27, 2020

Conditions

Keywords

Acute Myocardial InfarctionHeart AttackGender DifferencesRisk FactorsQuality of Care

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • Elevated cardiac markers within 24 hours of arrival at initial or enrolling institution
  • Supporting evidence suggestive of a heart attack

You may not qualify if:

  • Previously enrolled in the VIRGO study
  • Does not speak English or Spanish
  • Too ill to interview
  • Current prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (92)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0007, United States

Location

Providence Hospital

Mobile, Alabama, 36685, United States

Location

Sharp Gross Hospital

La Mesa, California, 91942, United States

Location

Saddleback Memorial Medical Center

Laguna Hills, California, 92653, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center/PRCC Cardiology Research

Los Angeles, California, 90048, United States

Location

Memorial Medical Center (Sutter Gould Medical Foundation)

Modesto, California, 95355, United States

Location

Sutter Medical Center Sacramento

Sacramento, California, 95819-3226, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

California Medical Center

San Francisco, California, 94120, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

St Joseph's Medical Center

Stockton, California, 95204, United States

Location

Los Robles Hospital and Medical Center

Thousand Oaks, California, 91360, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Centura Research Center

Denver, Colorado, 80210, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

St Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Hospital of St. Raphael

New Haven, Connecticut, 06511, United States

Location

Citrus Memorial Health Systems

Inverness, Florida, 34452, United States

Location

Baptist Cardiac & Vascular Institute, Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Pepin Heart Research Institute

Tampa, Florida, 33613, United States

Location

St Elizabeth's Hospital

Belleville, Illinois, 62220, United States

Location

Mercy Hospital and Medical Center

Chicago, Illinois, 60616, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Northshore University Health System

Evanston, Illinois, 60201, United States

Location

Memorial Health System

Springfield, Illinois, 62781, United States

Location

Parkview Hospital

Fort Wayne, Indiana, 46805, United States

Location

Krannert Heart Institute - Indiana University - Clarian Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

The Indiana Heart Hospital

Indianapolis, Indiana, 46250, United States

Location

St Vincent Hospital & Health Services

Indianapolis, Indiana, 46260, United States

Location

Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 54424, United States

Location

Cotton-O'Neil Clinical Research Center

Topeka, Kansas, 66604, United States

Location

Cardiovascular Research Foundation of Louisiana

Baton Rouge, Louisiana, 70808, United States

Location

Central Maine Heart and Vascular Institute

Lewiston, Maine, 04240, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Oakwood Hospital and Medical Center

Dearborn, Michigan, 48123, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

St John Hospital & Medical Center

Detroit, Michigan, 48236, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503-2528, United States

Location

Sparrow Hospital

Lansing, Michigan, 48909-7980, United States

Location

Mount Clemens Regional Medical Center

Mount Clemens, Michigan, 48043, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

St John's Regional Medical Center

Joplin, Missouri, 64804-1694, United States

Location

Mid-America Heart Institute, St Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Heartland Cardiovascular Consultants

Saint Joseph, Missouri, 64506, United States

Location

Cox South Hospital

Springfield, Missouri, 65804, United States

Location

St John's Medical Research Institute

Springfield, Missouri, 65807, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Glacier View Cardiology

Kalispell, Montana, 59901, United States

Location

The International Heart Institute of Montana

Missoula, Montana, 59802, United States

Location

Good Samaritan Hospital

Kearney, Nebraska, 68848, United States

Location

BryanLGH Heart Institute

Lincoln, Nebraska, 68506, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Overlook Hospital

Summit, New Jersey, 07929-0220, United States

Location

Presbyterian Heart Group

Albuquerque, New Mexico, 87106, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794-8167, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Montefiore/Albert Einstein Medical Center

The Bronx, New York, 10461, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7075, United States

Location

Presbyterian Hospital - Mid Carolina Cardiology

Charlotte, North Carolina, 28204, United States

Location

Presbysterian Hospital - Mid Carolina Cardiology

Charlotte, North Carolina, 78704, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Summa Health System (Akron City Hospital)

Akron, Ohio, 44309, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

St Rita's Medical Center

Lima, Ohio, 45801, United States

Location

Heart Institute of the Cascades

Bend, Oregon, 97701-6015, United States

Location

Samaritan Heart & Vascular Institute

Corvallis, Oregon, 97330, United States

Location

Butler Memorial Hospital

Butler, Pennsylvania, 16001, United States

Location

Geisinger Clinic - Cardiology

Danville, Pennsylvania, 17822-2160, United States

Location

Hamot Medical Center

Erie, Pennsylvania, 16550-0001, United States

Location

Pinnacle Health System

Harrisburg, Pennsylvania, 17101, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

D. Guthrie Foundation for Education & Research

Sayre, Pennsylvania, 18840, United States

Location

Sharon Regional Health System

Sharon, Pennsylvania, 16146, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Baylor Research Institute

Dallas, Texas, 75226, United States

Location

University of Texas Southwestern Medical Center at Dallas (UTSW)

Dallas, Texas, 75390-9034, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Sentara Hospital

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

St Mary's Medical Center

Huntington, West Virginia, 25702, United States

Location

Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Location

Related Publications (8)

  • Sawano M, Lu Y, Caraballo C, Mahajan S, Dreyer R, Lichtman JH, D'Onofrio G, Spatz E, Khera R, Onuma O, Murugiah K, Spertus JA, Krumholz HM. Sex Difference in Outcomes of Acute Myocardial Infarction in Young Patients. J Am Coll Cardiol. 2023 May 9;81(18):1797-1806. doi: 10.1016/j.jacc.2023.03.383.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Lindau ST, Abramsohn EM, Bueno H, D'Onofrio G, Lichtman JH, Lorenze NP, Mehta Sanghani R, Spatz ES, Spertus JA, Strait K, Wroblewski K, Zhou S, Krumholz HM. Sexual activity and counseling in the first month after acute myocardial infarction among younger adults in the United States and Spain: a prospective, observational study. Circulation. 2014 Dec 23;130(25):2302-9. doi: 10.1161/CIRCULATIONAHA.114.012709. Epub 2014 Dec 15.

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens for biomarker analysis and storage for future genetic studies

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Harlan M. Krumholz, MD, SM

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2008

First Posted

January 18, 2008

Study Start

September 1, 2007

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 30, 2020

Record last verified: 2014-06

Locations