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Lung cancer risk test trial: study design, participant baseline characteristics, bronchoscopy safety, and establishment of a biospecimen repository.
Crawford EL, Levin A, Safi F, Lu M, Baugh A, Zhang X, Yeo J, Khuder SA, Boulos AM, Nana-Sinkam P, Massion PP, Arenberg DA, Midthun D, Mazzone PJ, Nathan SD, Wainz R, Silvestri G, Tita J, Willey JC
(2016) BMC Pulm Med 16: 16
MeSH Terms: Aged, Aged, 80 and over, Agriculture, Asbestos, Biological Specimen Banks, Bronchi, Bronchoscopy, Cohort Studies, Early Detection of Cancer, Epithelial Cells, Female, Forced Expiratory Volume, Genetic Predisposition to Disease, Humans, Incidence, Lung Diseases, Obstructive, Lung Neoplasms, Male, Middle Aged, Occupational Exposure, Prospective Studies, Respiratory Mucosa, Risk Assessment, Smoking, Tomography, Spiral Computed, Vital Capacity
Show Abstract · Added February 16, 2016
BACKGROUND - The Lung Cancer Risk Test (LCRT) trial is a prospective cohort study comparing lung cancer incidence among persons with a positive or negative value for the LCRT, a 15 gene test measured in normal bronchial epithelial cells (NBEC). The purpose of this article is to describe the study design, primary endpoint, and safety; baseline characteristics of enrolled individuals; and establishment of a bio-specimen repository.
METHODS/DESIGN - Eligible participants were aged 50-90 years, current or former smokers with 20 pack-years or more cigarette smoking history, free of lung cancer, and willing to undergo bronchoscopic brush biopsy for NBEC sample collection. NBEC, peripheral blood samples, baseline CT, and medical and demographic data were collected from each subject.
DISCUSSION - Over a two-year span (2010-2012), 403 subjects were enrolled at 12 sites. At baseline 384 subjects remained in study and mean age and smoking history were 62.9 years and 50.4 pack-years respectively, with 34% current smokers. Obstructive lung disease (FEV1/FVC <0.7) was present in 157 (54%). No severe adverse events were associated with bronchoscopic brushing. An NBEC and matched peripheral blood bio-specimen repository was established. The demographic composition of the enrolled group is representative of the population for which the LCRT is intended. Specifically, based on baseline population characteristics we expect lung cancer incidence in this cohort to be representative of the population eligible for low-dose Computed Tomography (LDCT) lung cancer screening. Collection of NBEC by bronchial brush biopsy/bronchoscopy was safe and well-tolerated in this population. These findings support the feasibility of testing LCRT clinical utility in this prospective study. If validated, the LCRT has the potential to significantly narrow the population of individuals requiring annual low-dose helical CT screening for early detection of lung cancer and delay the onset of screening for individuals with results indicating low lung cancer risk. For these individuals, the small risk incurred by undergoing once in a lifetime bronchoscopic sample collection for LCRT may be offset by a reduction in their CT-related risks. The LCRT biospecimen repository will enable additional studies of genetic basis for COPD and/or lung cancer risk.
TRIAL REGISTRATION - The LCRT Study, NCT 01130285, was registered with Clinicaltrials.gov on May 24, 2010.
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26 MeSH Terms
Usefulness of biventricular volume as a predictor of mortality in patients with diabetes mellitus (from the Diabetes Heart Study).
Cox AJ, Hugenschmidt CE, Wang PT, Hsu FC, Kenchaiah S, Daniel K, Langefeld CD, Freedman BI, Herrington DM, Carr JJ, Stacey B, Bowden DW
(2013) Am J Cardiol 111: 1152-8
MeSH Terms: Adult, Aged, Aged, 80 and over, Cardiac-Gated Imaging Techniques, Carotid Intima-Media Thickness, Diabetes Mellitus, Type 2, Electrocardiography, Female, Heart Ventricles, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Predictive Value of Tests, Proportional Hazards Models, ROC Curve, Risk Factors, Stroke Volume, Tomography, Spiral Computed
Show Abstract · Added February 15, 2014
Patients with type 2 diabetes mellitus are at increased risk for cardiovascular disease (CVD) and mortality. Beyond traditional CVD risk factors, novel measures reflecting additional aspects of disease pathophysiology, such as biventricular volume (BiVV), may be useful for risk stratification. The aim of this study was to examine the relationship between BiVV and risk for mortality in European Americans with type 2 diabetes mellitus from the Diabetes Heart Study (DHS). BiVV was calculated from 771 noncontrast computed tomographic scans performed to image coronary artery calcified plaque. Relationships between BiVV and traditional CVD risk factors were examined. Cox proportional-hazards regression was performed to determine risk for mortality (all-cause and CVD mortality) associated with increasing BiVV. Area under the curve analysis was used to assess BiVV utility in risk prediction models. During 8.4 ± 2.4 years of follow-up, 23% of the patients died. In unadjusted analyses, BiVV was significantly associated with increasing body mass index, height, coronary artery calcified plaque, history of hypertension, and previous myocardial infarction (p <0.0001 to 0.012). BiVV was significantly associated with all-cause (hazard ratio 2.45, 95% confidence interval 1.06 to 5.67, p = 0.036) and CVD (hazard ratio 4.36, 95% confidence interval 1.36 to 14.03, p = 0.014) mortality in models adjusted for other known CVD risk factors. Area under the curve increased from 0.76 to 0.78 (p = 0.04) and from 0.74 to 0.77 (p = 0.02) for all-cause and CVD mortality with the inclusion of BiVV. In conclusion, in the absence of echocardiography or other noninvasive imaging modalities to assess ventricular volumes, or when such methods are contraindicated, BiVV from computed tomography may be considered a tool for the stratification of high-risk patients, such as those with type 2 diabetes mellitus.
Copyright © 2013 Elsevier Inc. All rights reserved.
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19 MeSH Terms
Primary cardiac lymphoma diagnosed by multiphase-gated cardiac CT and CT-guided percutaneous trans-sternal biopsy.
Shah RN, Simmons TW, Carr JJ, Entrikin DW
(2012) J Cardiovasc Comput Tomogr 6: 137-9
MeSH Terms: Aged, Biopsy, Needle, Cardiac-Gated Imaging Techniques, Heart Neoplasms, Humans, Lymphoma, B-Cell, Male, Predictive Value of Tests, Radiography, Interventional, Sternum, Tomography, Spiral Computed
Show Abstract · Added February 15, 2014
We present a case of a primary cardiac B-cell lymphoma where a multiphase-gated cardiac CT exam helped to successfully guide trans-sternal needle biopsy to establish a tissue diagnosis.
Copyright © 2012 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.
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11 MeSH Terms
Prediction of blunt traumatic injury in high-acuity patients: bedside examination vs computed tomography.
Smith CB, Barrett TW, Berger CL, Zhou C, Thurman RJ, Wrenn KD
(2011) Am J Emerg Med 29: 1-10
MeSH Terms: Abdominal Injuries, Adult, Confidence Intervals, Emergency Service, Hospital, Female, Head Injuries, Closed, Humans, Male, Middle Aged, Physical Examination, Point-of-Care Systems, Prospective Studies, ROC Curve, Sensitivity and Specificity, Spinal Injuries, Thoracic Injuries, Tomography, Spiral Computed, Wounds, Nonpenetrating
Show Abstract · Added January 20, 2015
OBJECTIVE - The addition of spiral computed tomography (SCT) to bedside assessment in patients with major trauma may improve detection of significant injury. We hypothesized that in high-acuity trauma patients, emergency physicians' ability to detect significant injuries based solely on bedside assessment would lack the sensitivity needed to exclude serious injuries when compared with SCT.
METHODS - This was a prospective single-cohort study of high-acuity trauma patients routinely undergoing whole-body SCT at a level 1 trauma center from January to September 2006. Before SCT, emergency physicians assigned ratings for likelihood of injury to 5 body regions on the basis of bedside assessment. These ratings were compared with final SCT interpretations.
RESULTS - We enrolled 400 patients as a convenience sample; 71 were excluded. When a "very low" rating was considered negative and "low," "intermediate," "high," and "very high" were considered positive, emergency physicians were able to detect head, cervical spine, chest, abdominal/pelvic, and thoracic/lumbar spine injuries with sensitivities (95% confidence interval) of 100% (98.6%-100%), 97.4% (94.9%-98.8%), 96.9% (94.2%-98.4%), 97.9% (95.5%-99.1%), and 97.0% (94.3%-98.5%), respectively. For overall diagnostic accuracy, areas under the receiver operating characteristics curve (95% confidence interval) were 0.87 (0.82-0.92), 0.71 (0.62-0.81), 0.81 (0.76-0.86), 0.77(0.71-0.83), 0.74 (0.65-0.84), respectively.
CONCLUSIONS - Bedside assessment by emergency physicians before SCT was sensitive in ruling out serious injuries in high-acuity trauma patients with a "very low" rating for injury. However, overall diagnostic accuracy was low, suggesting that SCT should be considered in most high-acuity patients to prevent missing injuries.
Copyright © 2011 Elsevier Inc. All rights reserved.
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18 MeSH Terms
Lipoprotein subclasses determined by nuclear magnetic resonance spectroscopy and coronary atherosclerosis in patients with rheumatoid arthritis.
Chung CP, Oeser A, Raggi P, Sokka T, Pincus T, Solus JF, Linton MF, Fazio S, Stein CM
(2010) J Rheumatol 37: 1633-8
MeSH Terms: Arthritis, Rheumatoid, Calcinosis, Coronary Angiography, Coronary Artery Disease, Female, Humans, Joints, Lipoproteins, Lipoproteins, HDL, Lipoproteins, LDL, Lipoproteins, VLDL, Magnetic Resonance Spectroscopy, Male, Middle Aged, Particle Size, Severity of Illness Index, Tomography, Spiral Computed
Show Abstract · Added December 10, 2013
OBJECTIVE - Patients with rheumatoid arthritis (RA) are at increased risk of atherosclerosis, but routine lipid measurements differ little from those of people without RA. We examined the hypothesis that lipid subclasses determined by nuclear magnetic resonance spectroscopy (NMR) differed in patients with RA compared to controls and are associated with disease activity and the presence of coronary-artery atherosclerosis.
METHODS - We measured lipoprotein subclasses by NMR in 139 patients with RA and 75 control subjects. Lipoproteins were classified as large low-density lipoprotein (LDL; diameter range 21.2-27.0 nm), small LDL (18.0-21.2 nm), large high-density lipoprotein (HDL; 8.2-13.0 nm), small HDL (7.3-8.2 nm), and total very low-density lipoprotein (VLDL; >or= 27 nm). All subjects underwent an interview and examination; disease activity was quantified by the 28-joint Disease Activity Score (DAS28) and coronary artery calcification (CAC) was measured with electron-beam computed tomography.
RESULTS - Concentrations of small HDL particles were lower in patients with RA (18.2 +/- 5.4 nmol/l) than controls (20.0 +/- 4.4 nmol/l; p = 0.003). In patients with RA, small HDL concentrations were inversely associated with DAS28 (rho = -0.18, p = 0.04) and C-reactive protein (rho = -0.25, p = 0.004). Concentrations of small HDL were lower in patients with coronary calcification (17.4 +/- 4.8 nmol/l) than in those without (19.0 +/- 5.8 nmol/l; p = 0.03). This relationship remained significant after adjustment for the Framingham risk score and DAS28 (p = 0.025). Concentrations of small LDL particles were lower in patients with RA (1390 +/- 722 nmol/l) than in controls (1518 +/- 654 nmol/l; p = 0.05), but did not correlate with DAS28 or CAC.
CONCLUSION - Low concentrations of small HDL particles may contribute to increased coronary atherosclerosis in patients with RA.
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17 MeSH Terms
Prevalence of incidental findings in trauma patients detected by computed tomography imaging.
Barrett TW, Schierling M, Zhou C, Colfax JD, Russ S, Conatser P, Lancaster P, Wrenn K
(2009) Am J Emerg Med 27: 428-35
MeSH Terms: Adult, Age Distribution, Emergencies, Female, Humans, Incidental Findings, Male, Middle Aged, Prevalence, Retrospective Studies, Sex Distribution, Tomography, Spiral Computed, United States, Wounds and Injuries
Show Abstract · Added January 20, 2015
STUDY OBJECTIVE - The primary intention of spiral computed tomography (SCT) in trauma patients is to identify significant injuries. However, unanticipated information is often discovered. We hypothesize that SCT often identifies clinically significant incidental findings in trauma patients.
METHODS - This was a retrospective protocol chart review of consecutive adult trauma patients seen at a level I trauma center. A complete SCT was defined as computed tomography imaging of the head, cervical spine, chest, abdomen, and pelvis, thoracic, and lumbar spine. Incidental findings were classified into 2 categories: type 1, which requires urgent evaluation, and type 2, which requires informing the patient but does not mandate urgent follow-up.
RESULTS - We reviewed 3246 patient charts and 3092 met inclusion criteria. Type 1 findings were reported in 990 (32.0%; 95% confidence interval [CI], 30.4%-33.7%) patients. Type 2 findings were found in 1274 (41.2%; 95% CI, 39.5%-42.9%) patients. Female sex (odds ratio, 1.38; 95% CI, 1.16-1.65) and older age (odds ratio, 2.61; 95% CI, 2.33-2.93) were independently associated with a higher prevalence of type 1 findings. There were 631 incidental findings concerning for neoplasm, which included 196 pulmonary nodules, 99 liver, 36 renal, 23 brain, and 11 breast masses.
CONCLUSIONS - A significant number of trauma patients evaluated with SCT are diagnosed with potentially serious incidental findings. For long-term care and medicolegal concerns, physicians need to inform patients of these incidental findings and the need for further evaluation.
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14 MeSH Terms
Effect of simvastatin (80 mg) on coronary and abdominal aortic arterial calcium (from the coronary artery calcification treatment with zocor [CATZ] study).
Terry JG, Carr JJ, Kouba EO, Davis DH, Menon L, Bender K, Chandler ET, Morgan T, Crouse JR
(2007) Am J Cardiol 99: 1714-7
MeSH Terms: Adult, Aged, Aorta, Abdominal, Calcinosis, Coronary Vessels, Female, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Male, Middle Aged, Simvastatin, Tomography, Spiral Computed
Show Abstract · Added February 28, 2014
We tested the hypothesis that, compared with placebo, simvastatin would reduce the progression of coronary artery calcium (CAC) and abdominal aortic calcium (AAC) levels in participants asymptomatic for vascular disease. Total CAC and AAC were measured with multidetector cardiac computed tomography. Inclusion criteria were a CAC score of >or=50 Agatston units, high-density lipoprotein (HDL) cholesterol levelor=2 other risk factors. Diabetes and history of vascular disease were exclusion criteria. Participants were randomized to receive 80 mg simvastatin (n=40) or matching placebo (n=40) for 12 months. Lipids were measured at 3-month intervals, and CAC and AAC measurements were repeated at 6 and 12 months. Total cholesterol, triglycerides, and LDL decreased significantly with simvastatin treatment (p<0.0001 for all comparisons, adjusted for baseline levels), whereas lipids remained unchanged for subjects randomized to receive placebo. Total CAC volume increased from baseline in both treatment groups. For subjects in the active treatment group, CAC volume increased by 9%, whereas in the placebo group, plaque volume increased by 5% (p=0.12 for treatment effect). AAC volume also increased in both treatment groups (p=0.15 for treatment effect). In conclusion, simvastatin treatment does not reduce progression of CAC or AAC compared with placebo.
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12 MeSH Terms
The impact of ethnicity and sex on subclinical cardiovascular disease: the Diabetes Heart Study.
Freedman BI, Hsu FC, Langefeld CD, Rich SS, Herrington DM, Carr JJ, Xu J, Bowden DW, Wagenknecht LE
(2005) Diabetologia 48: 2511-8
MeSH Terms: Adult, African Americans, Aged, Cardiovascular Diseases, Carotid Arteries, Carotid Stenosis, Cohort Studies, Coronary Vessels, Diabetes Mellitus, Type 2, Diabetic Angiopathies, European Continental Ancestry Group, Female, Humans, Male, Middle Aged, Risk Factors, Sex Characteristics, Tomography, Spiral Computed, Tunica Intima
Show Abstract · Added February 15, 2014
AIMS/HYPOTHESIS - African-Americans with type 2 diabetes and access to adequate healthcare are at lower risk of clinical coronary artery disease than are white diabetic patients. We evaluated whether ethnic differences in subclinical cardiovascular disease, coronary and carotid artery calcified plaque and carotid artery intima-medial thickness (IMT) were present in members of The Diabetes Heart Study families.
SUBJECTS AND METHODS - In a bi-racial cohort of 1,180 individuals from families enriched for members with type 2 diabetes, we calculated coronary and carotid artery calcified plaque using fast-gated helical computed tomography, and measured carotid artery IMT and clinical risk factor profiles. Generalised estimating equations were used to test for an association between measures of subclinical cardiovascular disease and ethnicity and sex.
RESULTS - After adjustment for age, ethnicity and kidney function, African-Americans had significantly lower amounts of coronary artery calcified plaque (mean+/-SE) (866+/-158 vs 1,915+/-135, respectively; p=0.0466) and carotid artery calcified plaque (179+/-51 vs 355+/-27, respectively; p=0.0240) relative to whites, despite having increased carotid IMT (0.71+/-0.01 vs 0.67+/-0.004 cm, respectively; p=0.0007), and higher blood pressure, albuminuria and HbA1c. Sex-specific analyses revealed that African-American men had significantly lower coronary and carotid artery calcified atheroma than white men. In women, ethnic differences in calcified carotid artery plaque, but not coronary artery plaque, were observed.
CONCLUSIONS/INTERPRETATION - In families enriched for members with type 2 diabetes, African-American men had markedly lower levels of coronary and carotid artery calcified plaque than white men, despite increased carotid artery IMT and conventional risk factors. These findings suggest that susceptibility to subclinical cardiovascular disease differs markedly according to ethnicity and sex.
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19 MeSH Terms
Changes in cardiovascular calcification after parathyroidectomy in patients with ESRD.
Bleyer AJ, Burkart J, Piazza M, Russell G, Rohr M, Carr JJ
(2005) Am J Kidney Dis 46: 464-9
MeSH Terms: Adult, Calcinosis, Carotid Artery Diseases, Coronary Angiography, Coronary Disease, Cross-Sectional Studies, Female, Humans, Hyperparathyroidism, Secondary, Kidney Failure, Chronic, Male, Middle Aged, Parathyroidectomy, Renal Dialysis, Tomography, Spiral Computed, Treatment Outcome
Show Abstract · Added February 15, 2014
BACKGROUND - The effect of parathyroidectomy on vascular calcification in patients with end-stage renal disease has been a subject of interest for many years, although studies in this area have not been definitive. The purpose of this investigation is to determine changes in vascular calcification after subtotal parathyroidectomy by using fast-gated helical computed axial tomographic imaging to measure coronary and carotid artery calcification.
METHODS - Computed tomographic imaging was performed at baseline and in follow-up on 10 patients who had undergone subtotal parathyroidectomy and 10 reference patients who had not undergone parathyroidectomy.
RESULTS - Patients who underwent subtotal parathyroidectomy had a mean change in coronary calcification of -92.3 +/- 469/y, and reference patients had a mean change of +479 +/- 630/y (P = 0.03). The 2 parathyroidectomy patients with the highest baseline scores had significant declines in both coronary and carotid calcification.
CONCLUSION - In this study, subtotal parathyroidectomy is associated with a significant decrease in vascular calcification in 2 of 10 dialysis patients with high coronary artery calcium scores and stabilization in 7 of 10 patients with low baseline scores.
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16 MeSH Terms
Novel strategies for the early detection and prevention of lung cancer.
Wardwell NR, Massion PP
(2005) Semin Oncol 32: 259-68
MeSH Terms: Anticarcinogenic Agents, Biomarkers, Tumor, Bronchoscopy, Gene Expression Profiling, Genomic Instability, Humans, Lung Neoplasms, Positron-Emission Tomography, Proteomics, Tomography, Spiral Computed
Show Abstract · Added March 5, 2014
Lung cancer is the leading cause of cancer death in the United States. Despite evidence of molecular abnormalities in biological specimens, progress in this disease is hampered by the lack of diagnostic markers useful for clinical practice. The majority of patients with lung cancer are still diagnosed at an advanced stage, when prognosis is poor. This article reviews new strategies being studied for the early detection of lung cancer. These strategies involve new methods of imaging (including low-dose computed tomography [CT] scanning), DNA analysis, and proteomic-based techniques. These strategies have not only improved our understanding of lung cancer but show promise in offering better survival to patients with this deadly disease. Of paramount importance in the search for methods of early detection is the need for the identification of the ideal population to screen, a multidisciplinary approach, and validation of promising techniques.
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10 MeSH Terms