Methods and processes for the reanalysis of the NINDS tissue plasminogen activator for acute ischemic stroke treatment trial.

Background: Treatment group imbalances in baseline stroke severity in the NINDS intravenous t-PA for acute stroke treatment trial led to controversy regarding the efficacy of tissue plasminogen activator (t-PA) in the treatment of acute ischemic stroke.

Purpose: Describe the steps used to independently re-evaluate this trial.

Methods: NIH appointed an independent multidisciplinary committee that gained access to the original data.

Do cardiovascular risk factors confer the same risk for cardiovascular outcomes in rheumatoid arthritis patients as in non-rheumatoid arthritis patients?

Objective: To compare the frequency of traditional cardiovascular (CV) risk factors in rheumatoid arthritis (RA) compared to non-RA subjects, and examine their impact on the risk of developing selected CV events (myocardial infarction (MI), heart failure (HF) and CV death) in these two groups.

Methods: We examined a population-based incidence cohort of subjects with RA (defined according to the 1987 American College of Rheumatology criteria), and an age- and sex-matched non-RA cohort. All subjects were followed longitudinally through their complete community medical records, until death, migration, or 1 January 2001.

Population-based study of the relationship between atherosclerotic aortic debris and cerebrovascular ischemic events.

Objective: To assess the validity of the suggestion that protruding atheromatous material in the thoracic aorta is an important cause of cerebrovascular ischemic events (CIEs) (ie, transient ischemic attack or ischemic stroke).

Methods: This case-control study of Olmsted County, Minnesota, residents who underwent transesophageal echocardiography (TEE) from 1993 to 1997 included controls without CIE randomly selected from the population, controls without CIE referred for TEE because of cardiac disease, cases with incident CIE of obvious cause (noncryptogenic), and cases with incident CIE of uncertain cause (cryptogenic).

Results: Of the 1135 subjects, 520 were randomly selected controls without CIE, 329 were controls without CIE referred for TEE, 159 were noncryptogenic CIE cases, and 127 were cryptogenic CIE cases.

Population-based study of the relationship between patent foramen ovale and cerebrovascular ischemic events.

Objective: To determine whether patent foramen ovale (PFO) is a risk factor for a cryptogenic cerebrovascular ischemic event (CIE).

Methods: This case-control study of 1072 residents of Olmsted County, Minnesota, who underwent contrast transesophageal echocardiography between 1993 and 1997 included 519 controls without CIE randomly selected from the population, 262 controls without CIE referred for transesophageal echocardiography because of cardiac disease, 158 cases with incident CIE of obvious cause (noncryptogenic), and 133 cases with incident CIE of uncertain cause (cryptogenic).

Results: Large PFOs were detected in 108 randomly selected controls (20.

Management strategy for very mild aortic valve stenosis.

It is unclear how often patients with very mild aortic stenosis (gradients < 25 mmHg) need interval follow-up. The purpose of this study was to define the determinants of disease severity progression and to propose appropriate management strategies. It is known that congenital aortic stenosis is a progressive disease that requires long-term follow-up at consistent intervals.

Patient, disease, and therapy-related factors that influence discontinuation of disease-modifying antirheumatic drugs: a population-based incidence cohort of patients with rheumatoid arthritis.

Objective: A major challenge in management of rheumatoid arthritis (RA) is prediction of longterm response to disease-modifying antirheumatic drug (DMARD) treatment. Our objective was to identify the predictors of DMARD discontinuation in an incidence cohort of patients with RA followed continuously from their incidence date.

Methods: Members of a population-based incidence cohort of Rochester, Minnesota, residents aged > or = 18 years diagnosed with RA (by 1987 American College of Rheumatology criteria) from January 1, 1955, to January 1, 1995, were followed longitudinally through their complete medical records until January 1, 2001.

How much of the increased incidence of heart failure in rheumatoid arthritis is attributable to traditional cardiovascular risk factors and ischemic heart disease?

Objective: To compare the proportion of the risk for the development of heart failure (HF) that is attributable to traditional cardiovascular (CV) risk factors, ischemic heart disease (IHD), and alcohol abuse between subjects with and subjects without rheumatoid arthritis (RA).

Methods: A population-based inception cohort of RA patients was assembled along with a similar cohort of subjects without RA. All individuals were followed up through their complete medical records, until HF incidence, death, migration, or January 1, 2001.

Outcomes among valvular heart disease patients experiencing ischemic stroke or transient ischemic attack in Olmsted County, Minnesota.

Objective: To estimate the rates and predictors of survival and recurrence among residents of Olmsted County, Minnesota, who received an Initial diagnosis based on 2-dimensional color Doppler echocardiography of moderate or severe mitral or aortic stenosis or regurgitation and who experienced a first ischemic stroke, transient ischemic attack (TIA), or amaurosis fugax.

Patients And Methods: At the Mayo Clinic in Rochester, Minn, we used the resources of the Rochester Epidemiology Project to identify Individuals who met the criteria for inclusion in the study and to verify exclusion criteria. The study included all residents of Olmsted County, Minnesota, who experienced a first Ischemic stroke, TIA, or amaurosis fugax within 30 days of or subsequent to receiving a first-time 2-dimensional color Doppler echocardlography-based diagnosis of moderate or severe mitral or aortic stenosis or regurgitation between January 1, 1985, and December 31, 1992.

Clinical, laboratory, and transesophageal echocardiographic correlates of interatrial septal thickness: a population-based transesophageal echocardiographic study.

Background: The determinants of interatrial septal (IAS) thickening ("lipomatous hypertrophy"), a common echocardiographic finding in the elderly, are poorly defined. The objective of this study was to determine the clinical, laboratory, and transesophageal echocardiographic correlates of IAS thickening in the general population.

Methods: The thickness of the IAS was measured by transesophageal echocardiography in 384 patients (median age: 66 years; range: 51-101 years; 53% men) participating in a population-based study (Stroke Prevention: Assessment of Risk in a Community).

Therapeutic strategies in rheumatoid arthritis over a 40-year period.

Objective: To examine trends in therapeutic strategies and to identify the determinants of starting disease modifying antirheumatic drug (DMARD) therapy over a 40-year period in a population based inception cohort of patients with rheumatoid arthritis (RA).

Methods: A population based inception cohort was assembled from among all Rochester, Minnesota, residents aged > or = 18 years who were first diagnosed with RA (1987 American College of Rheumatology criteria) between January 1, 1955, and January 1, 1995. All subjects were followed longitudinally through their complete medical records until death, migration from Olmsted County, or date of abstraction (January 1, 2001, to January 1, 2003).

Peripheral arterial disease, diabetes, and mortality.

Objective: The aims of this study were to provide estimates of 1) the risk of mortality for individuals with both diabetes and peripheral arterial disease (PAD) relative to that for individuals with either condition alone and 2) the association between PAD progression and mortality for individuals with diabetes, PAD, and both conditions.

Research Design And Methods: This longitudinal cohort study was conducted in Rochester, Minnesota. Local residents age 50-70 years with a prior diagnosis of PAD and/or diabetes were identified from the Mayo Clinic diagnostic registry and invited to a baseline examination (1977-1978).

C-reactive protein and atherosclerosis of the thoracic aorta: a population-based transesophageal echocardiographic study.

Background: An association between systemic inflammatory markers and the presence and severity of atherosclerotic plaques has not been demonstrated in a nonselected population. The purpose of this study was to examine the association of inflammatory markers with aortic atherosclerotic plaques in a sample of the general population and in a subgroup free of clinical vascular disease.

Methods: Transesophageal echocardiography was performed in 386 subjects (median age, 66 years; 53% men).

Findings from the reanalysis of the NINDS tissue plasminogen activator for acute ischemic stroke treatment trial.

Background And Purpose: Following publication of concerns about the results of the National Institute of Neurological Disorders and Stroke (NINDS) intravenous tissue plasminogen activator (t-PA) in acute stroke treatment trial, NINDS commissioned an independent committee "to address whether there is concern that eligible stroke patients may not benefit from t-PA given according to the protocol used in the trials and, whether the subgroup imbalance (in baseline stroke severity) invalidates the entire trial."

Methods: The original NINDS trial data were reanalyzed to assess the t-PA treatment effect, the effect of the baseline imbalance in stroke severity between the treatment groups on the t-PA treatment effect, and whether subgroups of patients did not benefit from receiving t-PA.

Results: A clinically important and statistically significant benefit of t-PA therapy was identified despite subgroup imbalances in baseline stroke severity and an increased incidence of symptomatic intracerebral hemorrhage in t-PA treated patients.

Incidence and characterization of diagnosed endometriosis in a geographically defined population.

Objective: We examined whether widespread use of laparoscopy was accompanied by increased diagnosis of asymptomatic endometriosis, inflated rates of diagnosis, or changes in the clinical spectrum of disease.

Design: Population-based cohort.

Setting: Olmsted County, Minnesota.

Inflammation, infection, and aortic valve sclerosis; Insights from the Olmsted County (Minnesota) population.

Atherosclerosis-related mechanisms, including inflammation and possibly infection, are likely to be involved in the pathogenesis of calcific aortic valve disease. The purpose of this study was to examine whether systemic inflammatory markers and Chlamydia pneumoniae seropositivity are associated with aortic valve sclerosis (AVS) in a sample of the general population. Transesophageal echocardiography was performed in 381 subjects (median age: 67 years, range: 51-101; 52% men), a sample of the adult population in Olmsted County, Minnesota.

Reappraisal of the epidemiology of giant cell arteritis in Olmsted County, Minnesota, over a fifty-year period.

Objective: To investigate time trends in the incidence and survival of giant cell arteritis (GCA) over a 50-year period in Olmsted County, Minnesota.

Methods: Using the unified record system at the Mayo Clinic, we identified all incident cases of GCA first diagnosed between 1950 and 1999. Incidence rates were estimated and adjusted to the 1980 United States white population for age and sex.

The effect of oral contraceptives and estrogen replacement therapy on the risk of rheumatoid arthritis: a population based study.

Objective: Epidemiologic evidence for a protective effect of exogenous female sex hormones on the development of rheumatoid arthritis (RA) is contradictory. We examined whether exposure to either oral contraceptives (OC) or postmenopausal estrogen replacement therapy (ERT) is associated with the development of RA in women.

Methods: We separately examined the relationship between use of OC and ERT on the risk of RA in a population based case-control study.

Prognostic markers of radiographic progression in early rheumatoid arthritis.

Objective: To identify prognostic markers that are predictive of progressive erosive disease in patients with early rheumatoid arthritis (RA).

Methods: The study involved an inception cohort of 111 consecutive patients with RA and a disease duration of <1 year. Patients were treated according to an algorithm designed to avoid overtreatment of mild disease and to accelerate treatment in patients who had continuous disease activity.

Provider satisfaction in clinical encounters with ethnic immigrant patients.

Objective: To determine whether physicians' satisfaction in clinical encounters with ethnic immigrant patients differs from satisfaction in clinical encounters with white patients in the local community.

Patients And Methods: Postvisit assessments from primary care physicians were collected for matched pairs of ethnic and control patients at the Mayo Clinic in Rochester, Minn, during a 10-week study (April 2-June 9, 2001). Ethnic patients were defined as first-generation Somalian, Cambodian, and Hispanic immigrants.

Glucocorticoid therapy in giant cell arteritis: duration and adverse outcomes.

Objective: To evaluate the course of glucocorticoid (GC) therapy and associated adverse events in a population-based cohort of patients with giant cell arteritis (GCA).

Methods: We identified 125 Olmsted County residents with GCA diagnosed between 1950 and 1991 and obtained followup information on the 120 patients who were diagnosed antemortem and agreed to participate in this study. Clinical variables, GC doses, and GC adverse events on each patient were recorded.

Is aortic dilatation an atherosclerosis-related process? Clinical, laboratory, and transesophageal echocardiographic correlates of thoracic aortic dimensions in the population with implications for thoracic aortic aneurysm formation.

Objectives: The study determined, in a population-based setting, whether dilatation of the thoracic aorta is an atherosclerosis-related process.

Background: The role of atherosclerosis in thoracic aortic dilatation and aneurysm formation is poorly defined.

Methods: The dimensions of the thoracic aorta were measured with transesophageal echocardiography in 373 subjects participating in a population-based study (median age 66 years; 52% men).

Risk of breast cancer and breast cancer characteristics in women treated with supradiaphragmatic radiation for Hodgkin lymphoma: Mayo Clinic experience.

Objective: To evaluate the overall risk of breast cancer and breast cancer characteristics in women given supradiaphragmatic radiation therapy for Hodgkin lymphoma.

Patients And Methods: Medical records of 653 female patients who received supradiaphragmatic radiation therapy for Hodgkin lymphoma at the Mayo Clinic in Rochester, Minn, between 1950 and 1993 were abstracted, and follow-up questionnaires were mailed. In 4 patients, breast cancer was diagnosed before Hodgkin lymphoma was discovered.

Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment.

Background: The management of unruptured intracranial aneurysms is controversial. Investigators from the International Study of Unruptured Intracranial Aneurysms aimed to assess the natural history of unruptured intracranial aneurysms and to measure the risk associated with their repair.

Methods: Centres in the USA, Canada, and Europe enrolled patients for prospective assessment of unruptured aneurysms.

Extra-articular disease manifestations in rheumatoid arthritis: incidence trends and risk factors over 46 years.

Objective: To investigate the trends in incidence of extra-articular rheumatoid arthritis (ExRA) in a well defined community based cohort of patients with rheumatoid arthritis (RA), and to examine possible predictors of ExRA occurrence.

Methods: Using the resources of the Rochester Epidemiology Project, a retrospective medical record review was conducted of a cohort of 609 cases of RA in Olmsted County, MN, diagnosed during 1955-94. These cases had been previously classified using the ACR 1987 criteria for RA.

Cause-specific mortality after first cerebral infarction: a population-based study.

Background And Purpose: Mortality after cerebral infarction (CI) has remained unchanged during the past 20 years, despite advances in neurologic care. Key factors affecting survival may be underrecognized. The purpose of this study was to determine the rate and cause of mortality after first CI.