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Article ; Online: Comment on Buckley et al. Intensive Versus Standard Blood Pressure Control in SPRINT-Eligible Participants of ACCORD-BP. Diabetes Care 2017;40:1733-1738.

Mi, Michael Y / Mukamal, Kenneth J

2018 Volume 41, Issue 6, Page(s) e84–e85

MeSH term(s)	Antihypertensive Agents ; Blood Pressure/drug effects ; Humans ; Hypertension
Chemical Substances	Antihypertensive Agents
Language	English
Publishing date	2018
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	441231-x
ISSN	1935-5548 ; 0149-5992
ISSN (online)	1935-5548
ISSN	0149-5992
DOI	10.2337/dc17-2482
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Zs.A 1434: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Plasma Proteomic Kinetics in Response to Acute Exercise.

Mi, Michael Y / Barber, Jacob L / Rao, Prashant / Farrell, Laurie A / Sarzynski, Mark A / Bouchard, Claude / Robbins, Jeremy M / Gerszten, Robert E

Molecular & cellular proteomics : MCP

2023 Volume 22, Issue 8, Page(s) 100601

Abstract: Regular exercise has many favorable effects on human health, which may be mediated in part by the release of circulating bioactive factors during each bout of exercise. Limited data exist regarding the kinetic responses of plasma proteins during and ... ...

Abstract	Regular exercise has many favorable effects on human health, which may be mediated in part by the release of circulating bioactive factors during each bout of exercise. Limited data exist regarding the kinetic responses of plasma proteins during and after acute exercise. Proteomic profiling of 4163 proteins was performed using a large-scale, affinity-based platform in 75 middle-aged adults who were referred for treadmill exercise stress testing. Plasma proteins were quantified at baseline, peak exercise, and 1-h postexercise, and those with significant changes at both exercise timepoints were further examined for their associations with cardiometabolic traits and change with aerobic exercise training in the Health, Risk Factors, Exercise Training and Genetics Family Study, a 20-week exercise intervention study. A total of 765 proteins changed (false discovery rate < 0.05) at peak exercise compared to baseline, and 128 proteins changed (false discovery rate < 0.05) at 1-h postexercise. The 56 proteins that changed at both timepoints included midkine, brain-derived neurotrophic factor, metalloproteinase inhibitor 4, and coiled-coil domain-containing protein 126 and were enriched for secreted proteins. The majority had concordant direction of change at both timepoints. Across all proteins assayed, gene set enrichment analysis showed increased abundance of coagulation-related proteins at 1-h postexercise. Forty-five proteins were associated with at least one measure of adiposity, lipids, glucose homeostasis, or cardiorespiratory fitness in Health, Risk Factors, Exercise Training and Genetics Family Study, and 20 proteins changed with aerobic exercise training. We identified hundreds of novel proteins that change during acute exercise, most of which resolved by 1 h into recovery. Proteins with sustained changes during exercise and recovery may be of particular interest as circulating biomarkers and pathways for further investigation in cardiometabolic diseases. These data will contribute to a biochemical roadmap of acute exercise that will be publicly available for the entire scientific community.
MeSH term(s)	Adult ; Middle Aged ; Humans ; Proteomics ; Kinetics ; Exercise/physiology ; Blood Proteins ; Cardiovascular Diseases
Chemical Substances	Blood Proteins
Language	English
Publishing date	2023-06-19
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2075924-1
ISSN	1535-9484 ; 1535-9476
ISSN (online)	1535-9484
ISSN	1535-9476
DOI	10.1016/j.mcpro.2023.100601
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Article ; Online: Early Administration of Antibiotics for Suspected Sepsis.

Mi, Michael Y / Klompas, Michael / Evans, Laura

The New England journal of medicine

2019 Volume 380, Issue 6, Page(s) 593–596

MeSH term(s)	Adult ; Aged ; Anti-Bacterial Agents/therapeutic use ; Clinical Decision-Making ; Female ; Humans ; Male ; Sepsis/drug therapy
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2019-02-06
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMclde1809210
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Article ; Online: An Unusual Cause of Functional Mitral Stenosis: A Left Atrial Intimal Sarcoma.

Diamond, Jamie E / Mi, Michael Y / VanderLaan, Paul A / Chu, Louis / Gelfand, Eli V

JACC. Case reports

2021 Volume 3, Issue 5, Page(s) 829–833

Abstract: Primary cardiac tumors are rare, with an incidence of <0.1% in postmortem series; sarcomas comprise 75% of these. Cardiac sarcomas may be life-threatening at the time of presentation. We describe a left atrial intimal sarcoma presenting with ... ...

Abstract	Primary cardiac tumors are rare, with an incidence of <0.1% in postmortem series; sarcomas comprise 75% of these. Cardiac sarcomas may be life-threatening at the time of presentation. We describe a left atrial intimal sarcoma presenting with constitutional symptoms, obstructive shock, and systemic emboli, and treated with proton beam therapy. (
Language	English
Publishing date	2021-04-28
Publishing country	Netherlands
Document type	Case Reports
ISSN	2666-0849
ISSN (online)	2666-0849
DOI	10.1016/j.jaccas.2021.02.043
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Article ; Online: Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome.

Mi, Michael Y / Matthay, Michael A / Morris, Alan H

The New England journal of medicine

2018 Volume 379, Issue 9, Page(s) 884–887

MeSH term(s)	Adult ; Extracorporeal Membrane Oxygenation/adverse effects ; Humans ; Influenza, Human/complications ; Male ; Respiration, Artificial/methods ; Respiratory Distress Syndrome, Adult/etiology ; Respiratory Distress Syndrome, Adult/therapy
Language	English
Publishing date	2018-08-29
Publishing country	United States
Document type	Journal Article
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMclde1804601
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Article ; Online: PFO Closure for Cryptogenic Stroke.

Mi, Michael Y / Block, Peter C / Broderick, Joseph P

The New England journal of medicine

2018 Volume 378, Issue 17, Page(s) 1639–1642

MeSH term(s)	Anticoagulants/therapeutic use ; Foramen Ovale, Patent/therapy ; Healthy Lifestyle ; Humans ; Male ; Middle Aged ; Secondary Prevention ; Stroke/prevention & control ; Thromboembolism/prevention & control
Chemical Substances	Anticoagulants
Language	English
Publishing date	2018--26
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMclde1715853
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Article: Association of Healthy Dietary Patterns and Cardiorespiratory Fitness in the Community.

Mi, Michael Y / Gajjar, Priya / Walker, Maura E / Miller, Patricia / Xanthakis, Vanessa / Murthy, Venkatesh L / Larson, Martin G / Vasan, Ramachandran S / Shah, Ravi V / Lewis, Gregory D / Nayor, Matthew

medRxiv : the preprint server for health sciences

2023

Abstract: Aims: To evaluate the associations of dietary indices and quantitative CRF measures in a large, community-based sample harnessing metabolomic profiling to interrogate shared biology.: Methods: Framingham Heart Study (FHS) participants underwent ... ...

Abstract	Aims: To evaluate the associations of dietary indices and quantitative CRF measures in a large, community-based sample harnessing metabolomic profiling to interrogate shared biology. Methods: Framingham Heart Study (FHS) participants underwent maximum effort cardiopulmonary exercise tests for CRF quantification (via peak VO Results: In 2380 FHS participants (54±9 years, 54% female, BMI 28±5 kg/m Conclusion: Higher diet quality is associated with greater CRF cross-sectionally in a middle-aged community-dwelling sample, and metabolites highlight potential shared favorable effects on health.
Language	English
Publishing date	2023-02-10
Publishing country	United States
Document type	Preprint
DOI	10.1101/2023.02.09.23285714
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Article ; Online: Association of healthy dietary patterns and cardiorespiratory fitness in the community.

European journal of preventive cardiology

2023 Volume 30, Issue 14, Page(s) 1450–1461

Abstract: Aims: To evaluate the associations of dietary indices and quantitative cardiorespiratory fitness (CRF) measures in a large, community-based sample harnessing metabolomic profiling to interrogate shared biology.: Methods and results: Framingham Heart ... ...

Abstract	Aims: To evaluate the associations of dietary indices and quantitative cardiorespiratory fitness (CRF) measures in a large, community-based sample harnessing metabolomic profiling to interrogate shared biology. Methods and results: Framingham Heart Study (FHS) participants underwent maximum effort cardiopulmonary exercise tests for CRF quantification (via peak VO2) and completed semi-quantitative food frequency questionnaires. Dietary quality was assessed by the Alternative Healthy Eating Index (AHEI) and Mediterranean-style Diet Score (MDS), and fasting blood concentrations of 201 metabolites were quantified. In 2380 FHS participants (54 ± 9 years, 54% female, body mass index 28 ± 5 kg/m2), 1 SD higher AHEI and MDS were associated with 5.2% (1.2 mL/kg/min, 95% CI 4.3-6.0%, P < 0.0001) and 4.5% (1.0 mL/kg/min, 95% CI 3.6-5.3%, P < 0.0001) greater peak VO2 in linear models adjusted for age, sex, total daily energy intake, cardiovascular risk factors, and physical activity. In participants with metabolite profiling (N = 1154), 24 metabolites were concordantly associated with both dietary indices and peak VO2 in multivariable-adjusted linear models (FDR < 5%). Metabolites that were associated with lower CRF and poorer dietary quality included C6 and C7 carnitines, C16:0 ceramide, and dimethylguanidino valeric acid, and metabolites that were positively associated with higher CRF and favourable dietary quality included C38:7 phosphatidylcholine plasmalogen and C38:7 and C40:7 phosphatidylethanolamine plasmalogens. Conclusion: Higher diet quality is associated with greater CRF cross-sectionally in a middle-aged community-dwelling sample, and metabolites highlight potential shared favourable effects on cardiometabolic health.
MeSH term(s)	Middle Aged ; Humans ; Female ; Male ; Cardiorespiratory Fitness ; Health Status ; Exercise ; Diet, Healthy ; Diet, Mediterranean
Language	English
Publishing date	2023-04-07
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	2626011-6
ISSN	2047-4881 ; 2047-4873
ISSN (online)	2047-4881
ISSN	2047-4873
DOI	10.1093/eurjpc/zwad113
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Zs.A 4686: Show issues

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Article ; Online: An analysis of adaptive design variations on the sequential parallel comparison design for clinical trials.

Mi, Michael Y / Betensky, Rebecca A

Clinical trials (London, England)

2013 Volume 10, Issue 2, Page(s) 207–215

Abstract: Background: Currently, a growing placebo response rate has been observed in clinical trials for antidepressant drugs, a phenomenon that has made it increasingly difficult to demonstrate efficacy. The sequential parallel comparison design (SPCD) is a ... ...

Abstract	Background: Currently, a growing placebo response rate has been observed in clinical trials for antidepressant drugs, a phenomenon that has made it increasingly difficult to demonstrate efficacy. The sequential parallel comparison design (SPCD) is a clinical trial design that was proposed to address this issue. The SPCD theoretically has the potential to reduce the sample-size requirement for a clinical trial and to simultaneously enrich the study population to be less responsive to the placebo. Purpose: Because the basic SPCD already reduces the placebo response by removing placebo responders between the first and second phases of a trial, the purpose of this study was to examine whether we can further improve the efficiency of the basic SPCD and whether we can do so when the projected underlying drug and placebo response rates differ considerably from the actual ones. Methods: Three adaptive designs that used interim analyses to readjust the length of study duration for individual patients were tested to reduce the sample-size requirement or increase the statistical power of the SPCD. Various simulations of clinical trials using the SPCD with interim analyses were conducted to test these designs through calculations of empirical power. Results: From the simulations, we found that the adaptive designs can recover unnecessary resources spent in the traditional SPCD trial format with overestimated initial sample sizes and provide moderate gains in power. Under the first design, results showed up to a 25% reduction in person-days, with most power losses below 5%. In the second design, results showed up to a 8% reduction in person-days with negligible loss of power. In the third design using sample-size re-estimation, up to 25% power was recovered from underestimated sample-size scenarios. Limitations: Given the numerous possible test parameters that could have been chosen for the simulations, the study's results are limited to situations described by the parameters that were used and may not generalize to all possible scenarios. Furthermore, dropout of patients is not considered in this study. Conclusions: It is possible to make an already complex design such as the SPCD adaptive, and thus more efficient, potentially overcoming the problem of placebo response at lower cost. Ultimately, such a design may expedite the approval of future effective treatments.
MeSH term(s)	Bias ; Clinical Trials as Topic/methods ; Computer Simulation ; Humans ; Placebos/administration & dosage ; Reproducibility of Results ; Research Design ; Sample Size
Chemical Substances	Placebos
Language	English
Publishing date	2013-01-02
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2138796-5
ISSN	1740-7753 ; 1740-7745
ISSN (online)	1740-7753
ISSN	1740-7745
DOI	10.1177/1740774512468806
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Zs.A 5831: Show issues

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Article ; Online: Clinical and Echocardiographic Factors Associated With In-Hospital Mortality in Patients With Infective Endocarditis Affecting the Native Tricuspid Valve.

Mi, Michael Y / Nelson, Sandra B / Weiner, Rory B

The American journal of cardiology

2016 Volume 118, Issue 5, Page(s) 739–743

Abstract: Infective endocarditis (IE) is a highly morbid disease, for which most outcomes data come from patients with left-sided valvular lesions. Echocardiographic findings such as vegetation size and prosthetic valve involvement have been identified as ... ...

Abstract	Infective endocarditis (IE) is a highly morbid disease, for which most outcomes data come from patients with left-sided valvular lesions. Echocardiographic findings such as vegetation size and prosthetic valve involvement have been identified as important predictors of mortality in left-sided IE, but predictors of outcomes in right-sided IE are less well characterized. Therefore, the aim of this study was to identify clinical and echocardiographic findings predictive of mortality in tricuspid valve (TV) IE. We retrospectively reviewed all echocardiograms showing TV vegetations that were performed at the Massachusetts General Hospital from January 1, 2003, to December 31, 2013. We identified 105 patients who had echocardiographic evidence of TV vegetations and a definite clinical diagnosis of IE based on the modified Duke's criteria but did not have intracardiac device-associated vegetations. Of the 105 patients, 88 survived until discharge. Clinical and echocardiographic factors that positively correlated with in-hospital mortality included age (p = 0.002), immunosuppression status (p = 0.016), blood urea nitrogen level (p = 0.029), Candida causative organism (p = 0.025), left ventricular ejection fraction <40% (p = 0.027), right ventricular (RV) systolic dysfunction (p = 0.009), and estimated RV systolic pressure >40 mm Hg (p = 0.040). Of these factors, immunosuppression status, blood urea nitrogen level, and RV systolic dysfunction were independently associated with increased in-hospital mortality. In conclusion, RV systolic dysfunction may serve as an echocardiographic marker to aid clinicians in identifying high-risk patients with right-sided IE for more aggressive therapy.
MeSH term(s)	Aged ; Echocardiography/methods ; Endocarditis/diagnosis ; Endocarditis/diagnostic imaging ; Endocarditis/mortality ; Female ; Hospital Mortality ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Retrospective Studies ; Risk Factors ; Tricuspid Valve/diagnostic imaging
Language	English
Publishing date	2016-06-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	80014-4
ISSN	1879-1913 ; 0002-9149
ISSN (online)	1879-1913
ISSN	0002-9149
DOI	10.1016/j.amjcard.2016.06.011
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