Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1000 participants
OBSERVATIONAL
2002-09-30
2008-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Postmenopausal Progestins, MI and Stroke
NCT00005220
Hormone Therapy Effects on CVD Risk Factors
NCT00006313
Myocardial Infarction and Non-contraceptive Estrogen Use
NCT00005185
Stroke and MI in Users of Estrogen/Progestogen
NCT00005466
Postmenopausal Hormone Therapy in Unstable Angina
NCT00000601
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Estrogens are prothrombotic. Recently, the Heart and Estrogen/progestin Replacement Study (HERS), renewed interest in the adverse effects of hormone replacement therapy (HRT). In HERS, HRT was no better than placebo at preventing coronary events. In post hoc analyses, treatment was associated with early harm and late benefit. In an American Heart Association funded case-control study, a potential interaction was observed between HRT and the prothrombin G20210A variant on the risk of first myocardial infarction (MI) in post-menopausal women with hypertension.
DESIGN NARRATIVE:
The study has a case-control design. The Group Health Cooperative (GHC) computerized files will be used to identify postmenopausal women, aged 30 to 79 yrs, with incident myocardial infarction (MI) or stroke during 1/2000-12/2004. Population-based controls, sampled from the GHC enrollment files, will be frequency matched to cases by age, calendar year, and treated hypertension. Data collection will include medical-record review, telephone interview of consenting subjects, and venous-blood collection. Standard methods will be used to assay variant alleles. The GHC computerized pharmacy records will serve as the primary source of information about the use of HRT. Data analysis will involve restriction, stratification, and logistic regression. Case-control and case-only analyses are planned. There will be a total of 600 MI cases, 420 stroke cases and 1800 controls.
The primary purpose is to examine the potential interactions of hormone replacement therapy with other procoagulant variants on the risk of cardiovascular events. The main variants of interest are: (la) factor XIIIA Val34Leu; (ib) platelet glycoprotein (PGP) Jib Ile843Ser; (ic) PGP IIIa Leu33Pro; and (id) PGP Ia C807T. The secondary aims include the assessment of other drug-gene, risk-factor-gene or gene-gene interactions on risk: (2a) the interaction between PGP IIb Ser843, PGP lila Leu33Pro and PGP Ia C807T and traditional cardiovascular risk factors such as smoking and obesity on the risk of MI and stroke; (2b) the interaction between three coagulation factor XIII polymorphisms and PAl-1 4G/5G on the risk of stroke in women; and (2c) the interaction between aspirin use and glycoprotein IIIa Leu33Pro on the risk of MI and stroke.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
30 Years
79 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Washington
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bruce Psaty
Professor, Medicine and Epidemiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bruce Psaty
Role: STUDY_CHAIR
University of Washington
References
Explore related publications, articles, or registry entries linked to this study.
Psaty BM, Lumley T, Furberg CD, Schellenbaum G, Pahor M, Alderman MH, Weiss NS. Health outcomes associated with various antihypertensive therapies used as first-line agents: a network meta-analysis. JAMA. 2003 May 21;289(19):2534-44. doi: 10.1001/jama.289.19.2534.
Rhoads CS, Psaty BM, Olson JL, Furberg CD. Medications and cardiovascular health in older adults: room for improvement in prevention and treatment. Am J Geriatr Cardiol. 2004 May-Jun;13(3):161-7. doi: 10.1111/j.1076-7460.2004.02124.x. No abstract available.
Smith NL, Heckbert SR, Lemaitre RN, Reiner AP, Lumley T, Weiss NS, Larson EB, Rosendaal FR, Psaty BM. Esterified estrogens and conjugated equine estrogens and the risk of venous thrombosis. JAMA. 2004 Oct 6;292(13):1581-7. doi: 10.1001/jama.292.13.1581.
Tirschwell DL, Smith NL, Heckbert SR, Lemaitre RN, Longstreth WT Jr, Psaty BM. Association of cholesterol with stroke risk varies in stroke subtypes and patient subgroups. Neurology. 2004 Nov 23;63(10):1868-75. doi: 10.1212/01.wnl.0000144282.42222.da.
Altorki N, Wang X, Damman B, Jones DR, Wigle D, Port J, Conti M, Ashrafi AS, Liberman M, Landreneau R, Yasufuku K, Yang S, Mitchell JD, Keenan R, Bauer T, Miller D, Kozono D, Mentlick J, Vokes E, Stinchcombe TE. Recurrence of Non-Small Cell Lung Cancer With Visceral Pleural Invasion: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2024 Sep 1;10(9):1179-1186. doi: 10.1001/jamaoncol.2024.2491.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20425
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.