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.
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
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.
- Conditions
- Acute Myocardial Infarction
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Harlan M. Krumholz, MD, SM, Principal investigator, Yale University
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 37137590Ding 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 33082173Ding 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 31441351Khera 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 30586733Safdar 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 29954744Lu 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 29848494Lu 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 28228461Lindau 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation in Recovery: Role of Gender on Outcomes of Young Acute Myocardial Infarction (AMI) Patients (VIRGO)
- ClinicalTrials.gov ID
- NCT00597922
- Acronym / sponsor ID
- VIRGO / 0507000374
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute Myocardial Infarction, Heart Attack, Gender Differences, Risk Factors, Quality of Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,985 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2007
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- Elevated cardiac markers within 24 hours of arrival at initial or enrolling institution
- Supporting evidence suggestive of a heart attack
Key exclusion criteria (4 listed)
- Previously enrolled in the VIRGO study
- Does not speak English or Spanish
- Too ill to interview
- Current prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Derived from this study: PubMed 37137590Sawano 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.
- Derived from this study: PubMed 33082173Ding 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.
- Derived from this study: PubMed 31441351Ding 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.
- Derived from this study: PubMed 30586733Khera 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.
- Derived from this study: PubMed 29954744Safdar 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.
- Derived from this study: PubMed 29848494Lu 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.
- Derived from this study: PubMed 28228461Lu 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.
- Derived from this study: PubMed 25512442Lindau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harlan M. Krumholz, MD, SM principal investigator
Yale University
92 sites in 1 country: see every site and its status.
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.