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Acute Myocardial InfarctionVIRGONCT00597922

Examining Heart Attacks in Young Women

An observational study of Acute Myocardial Infarction, run by Yale University at 92 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Acute Myocardial Infarction
How many people
2,985 participants
Where
92 sitesUnited States
Study dates
Sep 2007to Feb 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: 2,000 women and 1,000 men between the ages of 18 and 55 years who are hospitalized with a heart attack

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

92 sites in 1 country.

92 sites in 1 country

United States92 sites
  • Summa Health System (Akron City Hospital)

    Akron, Ohio, 44309

  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106

  • Cardiovascular Research Foundation of Louisiana

    Baton Rouge, Louisiana, 70808

  • St Elizabeth's Hospital

    Belleville, Illinois, 62220

  • Heart Institute of the Cascades

    Bend, Oregon, 97701-6015

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-0007

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Erie County Medical Center

    Buffalo, New York, 14215

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Butler Memorial Hospital

    Butler, Pennsylvania, 16001

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7075

  • Presbyterian Hospital - Mid Carolina Cardiology

    Charlotte, North Carolina, 28204

  • Presbysterian Hospital - Mid Carolina Cardiology

    Charlotte, North Carolina, 78704

  • Mercy Hospital and Medical Center

    Chicago, Illinois, 60616

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Samaritan Heart & Vascular Institute

    Corvallis, Oregon, 97330

  • Baylor Research Institute

    Dallas, Texas, 75226

  • University of Texas Southwestern Medical Center at Dallas (UTSW)

    Dallas, Texas, 75390-9034

  • Geisinger Clinic - Cardiology

    Danville, Pennsylvania, 17822-2160

  • Genesis Medical Center

    Davenport, Iowa, 52803

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • Centura Research Center

    Denver, Colorado, 80210

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • St John Hospital & Medical Center

    Detroit, Michigan, 48236

  • Hamot Medical Center

    Erie, Pennsylvania, 16550-0001

  • Northshore University Health System

    Evanston, Illinois, 60201

  • Parkview Hospital

    Fort Wayne, Indiana, 46805

  • Spectrum Health

    Grand Rapids, Michigan, 49503-2528

  • Pinnacle Health System

    Harrisburg, Pennsylvania, 17101

  • St Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • St Mary's Medical Center

    Huntington, West Virginia, 25702

  • Krannert Heart Institute - Indiana University - Clarian Methodist Hospital

    Indianapolis, Indiana, 46202

  • The Indiana Heart Hospital

    Indianapolis, Indiana, 46250

  • St Vincent Hospital & Health Services

    Indianapolis, Indiana, 46260

  • Citrus Memorial Health Systems

    Inverness, Florida, 34452

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 54424

  • St John's Regional Medical Center

    Joplin, Missouri, 64804-1694

  • Glacier View Cardiology

    Kalispell, Montana, 59901

  • Mid-America Heart Institute, St Luke's Hospital

    Kansas City, Missouri, 64111

  • Good Samaritan Hospital

    Kearney, Nebraska, 68848

  • Sharp Gross Hospital

    La Mesa, California, 91942

  • Saddleback Memorial Medical Center

    Laguna Hills, California, 92653

  • Sparrow Hospital

    Lansing, Michigan, 48909-7980

  • Central Maine Heart and Vascular Institute

    Lewiston, Maine, 04240

  • St Rita's Medical Center

    Lima, Ohio, 45801

  • BryanLGH Heart Institute

    Lincoln, Nebraska, 68506

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • University of Southern California

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center/PRCC Cardiology Research

    Los Angeles, California, 90048

  • Baptist Cardiac & Vascular Institute, Baptist Hospital of Miami

    Miami, Florida, 33176

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • The International Heart Institute of Montana

    Missoula, Montana, 59802

  • Providence Hospital

    Mobile, Alabama, 36685

  • Memorial Medical Center (Sutter Gould Medical Foundation)

    Modesto, California, 95355

  • Mount Clemens Regional Medical Center

    Mount Clemens, Michigan, 48043

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Hospital of St. Raphael

    New Haven, Connecticut, 06511

  • Sentara Hospital

    Norfolk, Virginia, 23507

  • Orlando Health

    Orlando, Florida, 32806

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Sutter Medical Center Sacramento

    Sacramento, California, 95819-3226

  • Mercy General Hospital

    Sacramento, California, 95819

  • Heartland Cardiovascular Consultants

    Saint Joseph, Missouri, 64506

  • California Medical Center

    San Francisco, California, 94120

  • D. Guthrie Foundation for Education & Research

    Sayre, Pennsylvania, 18840

  • Sharon Regional Health System

    Sharon, Pennsylvania, 16146

  • Memorial Health System

    Springfield, Illinois, 62781

  • Cox South Hospital

    Springfield, Missouri, 65804

  • St John's Medical Research Institute

    Springfield, Missouri, 65807

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • St Joseph's Medical Center

    Stockton, California, 95204

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794-8167

  • Overlook Hospital

    Summit, New Jersey, 07929-0220

  • Pepin Heart Research Institute

    Tampa, Florida, 33613

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • Montefiore/Albert Einstein Medical Center

    The Bronx, New York, 10461

  • Los Robles Hospital and Medical Center

    Thousand Oaks, California, 91360

  • Cotton-O'Neil Clinical Research Center

    Topeka, Kansas, 66604

  • Torrance Memorial Medical Center

    Torrance, California, 90505

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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.

Read the 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.

Keywords
Acute Myocardial Infarction, Heart Attack, Gender Differences, Risk Factors, Quality of Care
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00597922
Study groupRoleWhat they receive
12,000 women between the ages of 18 and 55 years who are hospitalized with a heart attack
21,000 men between the ages of 18 and 55 years who are hospitalized with a heart attack

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,985 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00597922
Sponsor's protocol ID
0507000374
Other IDs
R01HL081153-01A1
Acronym
VIRGO
Status last verified
Jun 2014
First submitted
9 Jan 2008
Last updated
30 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 37137590
  • 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.

    PubMed 33082173
  • 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.

    PubMed 31441351
  • 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.

    PubMed 30586733
  • 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.

    PubMed 29954744
  • 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.

    PubMed 29848494
  • 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.

    PubMed 28228461
  • 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.

    PubMed 25512442

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Infarction, run by Yale University at 92 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00597922, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.

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