Examining Heart Attacks in Young Women

NCT ID: NCT00597922

Last Updated: 2020-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2985 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-02-28

Brief Summary

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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

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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.

Conditions

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Acute Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

2,000 women between the ages of 18 and 55 years who are hospitalized with a heart attack

No interventions assigned to this group

2

1,000 men between the ages of 18 and 55 years who are hospitalized with a heart attack

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harlan M. Krumholz, MD, SM

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Providence Hospital

Mobile, Alabama, United States

Site Status

Sharp Gross Hospital

La Mesa, California, United States

Site Status

Saddleback Memorial Medical Center

Laguna Hills, California, United States

Site Status

Long Beach Memorial Medical Center

Long Beach, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

Cedars-Sinai Medical Center/PRCC Cardiology Research

Los Angeles, California, United States

Site Status

Memorial Medical Center (Sutter Gould Medical Foundation)

Modesto, California, United States

Site Status

Sutter Medical Center Sacramento

Sacramento, California, United States

Site Status

Mercy General Hospital

Sacramento, California, United States

Site Status

California Medical Center

San Francisco, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

St Joseph's Medical Center

Stockton, California, United States

Site Status

Los Robles Hospital and Medical Center

Thousand Oaks, California, United States

Site Status

Torrance Memorial Medical Center

Torrance, California, United States

Site Status

Denver Health Medical Center

Denver, Colorado, United States

Site Status

Centura Research Center

Denver, Colorado, United States

Site Status

Bridgeport Hospital

Bridgeport, Connecticut, United States

Site Status

St Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Hospital of St. Raphael

New Haven, Connecticut, United States

Site Status

Citrus Memorial Health Systems

Inverness, Florida, United States

Site Status

Baptist Cardiac & Vascular Institute, Baptist Hospital of Miami

Miami, Florida, United States

Site Status

Orlando Health

Orlando, Florida, United States

Site Status

Pepin Heart Research Institute

Tampa, Florida, United States

Site Status

St Elizabeth's Hospital

Belleville, Illinois, United States

Site Status

Mercy Hospital and Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Northshore University Health System

Evanston, Illinois, United States

Site Status

Memorial Health System

Springfield, Illinois, United States

Site Status

Parkview Hospital

Fort Wayne, Indiana, United States

Site Status

Krannert Heart Institute - Indiana University - Clarian Methodist Hospital

Indianapolis, Indiana, United States

Site Status

The Indiana Heart Hospital

Indianapolis, Indiana, United States

Site Status

St Vincent Hospital & Health Services

Indianapolis, Indiana, United States

Site Status

Genesis Medical Center

Davenport, Iowa, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Cotton-O'Neil Clinical Research Center

Topeka, Kansas, United States

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Cardiovascular Research Foundation of Louisiana

Baton Rouge, Louisiana, United States

Site Status

Central Maine Heart and Vascular Institute

Lewiston, Maine, United States

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Boston Medical Center

Boston, Massachusetts, United States

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Oakwood Hospital and Medical Center

Dearborn, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

St John Hospital & Medical Center

Detroit, Michigan, United States

Site Status

Spectrum Health

Grand Rapids, Michigan, United States

Site Status

Sparrow Hospital

Lansing, Michigan, United States

Site Status

Mount Clemens Regional Medical Center

Mount Clemens, Michigan, United States

Site Status

Munson Medical Center

Traverse City, Michigan, United States

Site Status

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Site Status

St John's Regional Medical Center

Joplin, Missouri, United States

Site Status

Mid-America Heart Institute, St Luke's Hospital

Kansas City, Missouri, United States

Site Status

Heartland Cardiovascular Consultants

Saint Joseph, Missouri, United States

Site Status

Cox South Hospital

Springfield, Missouri, United States

Site Status

St John's Medical Research Institute

Springfield, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Site Status

Glacier View Cardiology

Kalispell, Montana, United States

Site Status

The International Heart Institute of Montana

Missoula, Montana, United States

Site Status

Good Samaritan Hospital

Kearney, Nebraska, United States

Site Status

BryanLGH Heart Institute

Lincoln, Nebraska, United States

Site Status

The Valley Hospital

Ridgewood, New Jersey, United States

Site Status

Overlook Hospital

Summit, New Jersey, United States

Site Status

Presbyterian Heart Group

Albuquerque, New Mexico, United States

Site Status

Erie County Medical Center

Buffalo, New York, United States

Site Status

Winthrop University Hospital

Mineola, New York, United States

Site Status

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status

Jacobi Medical Center

The Bronx, New York, United States

Site Status

Montefiore/Albert Einstein Medical Center

The Bronx, New York, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Presbyterian Hospital - Mid Carolina Cardiology

Charlotte, North Carolina, United States

Site Status

Presbysterian Hospital - Mid Carolina Cardiology

Charlotte, North Carolina, United States

Site Status

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Summa Health System (Akron City Hospital)

Akron, Ohio, United States

Site Status

The Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

St Rita's Medical Center

Lima, Ohio, United States

Site Status

Heart Institute of the Cascades

Bend, Oregon, United States

Site Status

Samaritan Heart & Vascular Institute

Corvallis, Oregon, United States

Site Status

Butler Memorial Hospital

Butler, Pennsylvania, United States

Site Status

Geisinger Clinic - Cardiology

Danville, Pennsylvania, United States

Site Status

Hamot Medical Center

Erie, Pennsylvania, United States

Site Status

Pinnacle Health System

Harrisburg, Pennsylvania, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

D. Guthrie Foundation for Education & Research

Sayre, Pennsylvania, United States

Site Status

Sharon Regional Health System

Sharon, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Baylor Research Institute

Dallas, Texas, United States

Site Status

University of Texas Southwestern Medical Center at Dallas (UTSW)

Dallas, Texas, United States

Site Status

Fletcher Allen Health Care

Burlington, Vermont, United States

Site Status

Sentara Hospital

Norfolk, Virginia, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

St Mary's Medical Center

Huntington, West Virginia, United States

Site Status

Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37137590 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33082173 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31441351 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30586733 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29954744 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29848494 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28228461 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25512442 (View on PubMed)

Other Identifiers

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R01HL081153-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0507000374

Identifier Type: -

Identifier Source: org_study_id

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