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Item Cardiovascular Adaptation in Athletes(Elsevier, 2016-01) Kovacs, Richard; Baggish, Aaron L.; Department of Medicine, IU School of MedicineMillions of athletes train for and participate in competitive athletics each year. Many of these athletes will present to a cardiovascular specialist with signs or symptoms that might indicate heart disease and these athletes/patients will ask for advice on their ability to continue to train and compete safely. By virtue of their training, athletes׳ hearts may undergo significant structural and electrical change, presenting a special challenge for the cardiovascular specialist. It is important to understand normal adaptive changes in order to separate normal physiology from pathology.Item A Menopause Strategies–Finding Lasting Answers for Symptoms and Health (MsFLASH) Investigation of Self-Reported Menopausal Palpitation Distress(Liebert, 2021-04) Carpenter, Janet S.; Tisdale, James E.; Chen, Chen X.; Kovacs, Richard; Larson, Joseph C.; Guthrie, Katherine A.; Ensrud, Kristine E; Newton, Katherine M.; LaCroix, Andrea Z.Background: Study to describe the degree of menopausal palpitation distress and its demographic, clinical, symptom, and quality-of-life (QOL) correlates. Analysis of existing, baseline, data from peri- and postmenopausal women, 42 to 62 years of age, who participated in the Menopause Strategies–Finding Lasting Answers for Symptoms and Health (MsFLASH) clinical trials testing interventions for vasomotor symptoms (n = 759). Up to 46.8% of menopausal women report having palpitations, yet the symptom is relatively understudied. Little is known about palpitation distress or its correlates. Materials and Methods: Degree of distress from “heart racing or pounding” was self-reported over the past two weeks as “not at all,” “a little bit,” “moderately,” “quite a bit,” or “extremely.” Other measures included self-report forms, clinic-verified body mass index (BMI), vasomotor symptom diaries, and validated symptom and QOL tools. Results: The percentage who reported palpitation distress was 19.6%, 25.2%, and 33.5% in the three trials or 25.0% overall. In multivariate analysis, the odds of reporting palpitation distress was lower in past smokers (odds ratio [OR] = 0.59 [95% confidence interval (CI) 0.38–0.90]) and current smokers (OR = 0.48 [0.27–0.87]) relative to never-smokers and lower with every 5 kg/m2 higher BMI (OR = 0.82 [0.69–0.98]).The odds of reporting palpitation distress was higher with every five point more severe insomnia (OR = 1.28 [1.05–1.54]), five point worse depressive symptoms (OR = 1.47 [1.11–1.95]), five point worse perceived stress (OR = 1.19 [1.01–1.39]), and one point worse menopausal QOL (OR = 1.29 [1.06–1.57]). Conclusions: Menopausal palpitation distress is common and associated with demographic, clinical, symptom, and QOL factors. Findings can be used for screening in clinical practice and to justify additional research on this understudied symptom.Item MsFLASH Analysis of Diurnal Salivary Cortisol and Palpitations in Peri and Postmenopausal Women(Wolters Kluwer, 2021-11-29) Carpenter, Janet S.; Tisdale, James E.; Larson, Joseph C.; Sheng, Ying; Chen, Chen X.; Von Ah, Diane; Kovacs, Richard; Reed, Susan D.; Thurston, Rebecca C.; Guthrie, Katherine A.; School of NursingObjective: To evaluate the relationship between diurnal salivary cortisol patterns and distress from heart palpitations in midlife women. Methods: We analyzed baseline data from 293 women who were eligible for a 3 × 2 factorial trial of exercise or yoga versus routine activity, and omega-3 fish oil versus placebo for vasomotor symptoms. Women self-collected salivary cortisol using swabs at four time points over 2 consecutive days and reported distress from heart racing or pounding during the past 2 weeks using a single item. Sample description and covariate data included demographics, clinical data, vasomotor symptom frequency from daily diaries, medication use, and validated questionnaires on depression, stress, and insomnia (Patient Health Questionnaire-8, Perceived Stress Scale, and Insomnia Severity index). Data were analyzed using descriptive statistics, chi-square and t tests, and repeated measure linear regression models. Results: Participants were on average 54.6 (SD = 3.6) years old, most were White (67%) postmenopausal (84%), and 26% reported distress related to palpitations. In adjusted models, the morning (wake plus 30-min) geometric mean daily salivary cortisol concentrations were significantly more blunted in those with distress from palpitations compared with those without distress (P ≤ 0.03). When all covariates were controlled, distress from palpitations was the sole significant predictor of wake plus 30-minute cortisol (-0.25 [-0.45 to -0.04], P = 0.02). Conclusions: Palpitations among midlife women may be associated with blunted morning cortisol, and this relationship is not explained by demographics, clinical variables, vasomotor symptoms, medications, depression, stress, or insomnia.Item Prevalence of Clinical and Subclinical Myocarditis in Competitive Athletes With Recent SARS-CoV-2 Infection: Results From the Big Ten COVID-19 Cardiac Registry(AMA, 2021-05-27) Daniels, Curt J.; Rajpal, Saurabh; Greenshields, Joel T.; Rosenthal, Geoffrey L.; Chung, Eugene H.; Terrin, Michael; Jeudy, Jean; Mattson, Scott E.; Law, Ian H.; Borchers, James; Kovacs, Richard; Kovan, Jeffrey; Rifat, Sami F.; Albrecht, Jennifer; Bento, Ana I.; Albers, Lonnie; Bernhardt, David; Day, Carly; Hecht, Suzanne; Hipskind, Andrew; Mjaanes, Jeffrey; Olson, David; Rooks, Yvette L.; Somers, Emily C.; Tong, Matthew S.; Wisinski, Jeffrey; Womack, Jason; Esopenko, Carrie; Kratochvil, Christopher J.; Rink, Lawrence D.; Medicine, School of MedicineImportance: Myocarditis is a leading cause of sudden death in competitive athletes. Myocardial inflammation is known to occur with SARS-CoV-2. Different screening approaches for detection of myocarditis have been reported. The Big Ten Conference requires comprehensive cardiac testing including cardiac magnetic resonance (CMR) imaging for all athletes with COVID-19, allowing comparison of screening approaches. Objective: To determine the prevalence of myocarditis in athletes with COVID-19 and compare screening strategies for safe return to play. Design, Setting, and Participants: Big Ten COVID-19 Cardiac Registry principal investigators were surveyed for aggregate observational data from March 1, 2020, through December 15, 2020, on athletes with COVID-19. For athletes with myocarditis, presence of cardiac symptoms and details of cardiac testing were recorded. Myocarditis was categorized as clinical or subclinical based on the presence of cardiac symptoms and CMR findings. Subclinical myocarditis classified as probable or possible myocarditis based on other testing abnormalities. Myocarditis prevalence across universities was determined. The utility of different screening strategies was evaluated. Exposures: SARS-CoV-2 by polymerase chain reaction testing. Main Outcome and Measure: Myocarditis via cardiovascular diagnostic testing. Results: Representing 13 universities, cardiovascular testing was performed in 1597 athletes (964 men [60.4%]). Thirty-seven (including 27 men) were diagnosed with COVID-19 myocarditis (overall 2.3%; range per program, 0%-7.6%); 9 had clinical myocarditis and 28 had subclinical myocarditis. If cardiac testing was based on cardiac symptoms alone, only 5 athletes would have been detected (detected prevalence, 0.31%). Cardiac magnetic resonance imaging for all athletes yielded a 7.4-fold increase in detection of myocarditis (clinical and subclinical). Follow-up CMR imaging performed in 27 (73.0%) demonstrated resolution of T2 elevation in all (100%) and late gadolinium enhancement in 11 (40.7%). Conclusions and Relevance: In this cohort study of 1597 US competitive athletes with CMR screening after COVID-19 infection, 37 athletes (2.3%) were diagnosed with clinical and subclinical myocarditis. Variability was observed in prevalence across universities, and testing protocols were closely tied to the detection of myocarditis. Variable ascertainment and unknown implications of CMR findings underscore the need for standardized timing and interpretation of cardiac testing. These unique CMR imaging data provide a more complete understanding of the prevalence of clinical and subclinical myocarditis in college athletes after COVID-19 infection. The role of CMR in routine screening for athletes safe return to play should be explored further.Item Pridopidine Does Not Significantly Prolong the QTc Interval at the Clinically Relevant Therapeutic Dose(Springer, 2023) Darpo, Borje; Geva, Michal; Ferber, Georg; Goldberg, Yigal Paul; Cruz-Herranz, Andres; Mehra, Munish; Kovacs, Richard; Hayden, Michael R.; Medicine, School of MedicineIntroduction: Pridopidine is a highly selective sigma-1 receptor (S1R) agonist in development for the treatment of Huntington's disease (HD) and amyotrophic lateral sclerosis (ALS). Pridopidine's activation of S1R enhances cellular processes that are crucial for neuronal function and survival but are impaired in neurodegenerative diseases. Human brain positron emission tomography (PET) imaging studies show that at the therapeutic dose of 45 mg twice daily (bid), pridopidine selectively and robustly occupies the S1R. We conducted concentration-QTc (C-QTc) analyses to assess pridopidine's effect on the QT interval and investigated its cardiac safety profile. Methods: C-QTc analysis was conducted using data from PRIDE-HD, a phase 2, placebo-controlled trial evaluating four pridopidine doses (45, 67.5, 90, 112.5 mg bid) or placebo over 52 weeks in HD patients. Triplicate electrocardiograms (ECGs) with simultaneous plasma drug concentrations were determined in 402 patients with HD. The effect of pridopidine on the Fridericia-corrected QT interval (QTcF) was evaluated. Cardiac-related adverse events (AEs) were analyzed from PRIDE-HD alone and from pooled safety data of three double-blind, placebo-controlled trials with pridopidine in HD (HART, MermaiHD, and PRIDE-HD). Results: A concentration-dependent effect of pridopidine on the change from baseline in the Fridericia-corrected QT interval (ΔQTcF) was observed, with a slope of 0.012 ms (ms) per ng/mL (90% confidence interval (CI), 0.0109-0.0127). At the therapeutic dose of 45 mg bid, the predicted placebo-corrected ΔQTcF (ΔΔQTcF) was 6.6 ms (upper bound 90% CI, 8.0 ms), which is below the level of concern and not clinically relevant. Analysis of pooled safety data from three HD trials demonstrates that at 45 mg bid, pridopidine cardiac-related AE frequencies are similar to those with placebo. No patients reached a QTcF of 500 ms and no patients experienced torsade de pointes (TdP) at any pridopidine dose. Conclusions: At the 45 mg bid therapeutic dose, pridopidine demonstrates a favorable cardiac safety profile, with an effect on the QTc interval that is below the level of concern and not clinically relevant.Item Skin Sympathetic Nerve Activity as a Biomarker for Neurological Recovery during Therapeutic Hypothermia for Cardiac Arrest(Elsevier, 2021) Kutkut, Issa; Uceda, Domingo; Kumar, Awaneesh; Wong, Johnson; Li, Xiaochun; Wright, Keith C.; Straka, Susan; Adams, David; Deckard, Michelle; Kovacs, Richard; Chen, Peng-Sheng; Everett, Thomas H., IV.; Medicine, School of MedicineBackground: Targeted temperature management (TTM) improves neurologic outcome after cardiac arrest. However, better neurologic prognostication is needed. Objective: The purpose of this study was to test the hypothesis that noninvasive recording of skin sympathetic nerve activity (SKNA) and its association with heart rate (HR) during TTM may serve as a biomarker of neurologic status. Methods: SKNA recordings were analyzed from 29 patients undergoing TTM. Patients were grouped based on Clinical Performance Category (CPC) score into group 1 (CPC 1-2) representing a good neurologic outcome and group 2 (CPC 3-5) representing a poor neurologic outcome. Results: Of the 29 study participants, 18 (62%) were deemed to have poor neurologic outcome. At all timepoints, low average skin sympathetic nerve activity (aSKNA) was associated with poor neurologic outcome (odds ratio 22.69; P = .002) and remained significant (P = .03) even when adjusting for presenting clinical factors. The changes in aSKNA and HR during warming in group 1 were significantly correlated (ρ = 0.49; P <.001), even when adjusting for corresponding temperature and mean arterial pressure measurements (P = .017), whereas this correlation was not observed in group 2. Corresponding to high aSKNA, there was increased nerve burst activity during warming in group 1 compared to group 2 (0.739 ± 0.451 vs 0.176 ± 0.231; P = .013). Conclusion: Neurologic recovery was retrospectively associated with SKNA. Patients undergoing TTM who did not achieve neurologic recovery were associated with low SKNA and lacked a significant correlation between SKNA and HR. These preliminary results indicate that SKNA may potentially be a useful biomarker to predict neurologic status in patients undergoing TTM.Item Taking a stand against air pollution – the impact on cardiovascular disease: A Joint Opinion from the World Heart Federation, American College of Cardiology, American Heart Association, and the European Society of Cardiology(Oxford, 2021-01) Brauer, Michael; Casadei, Barbara; Harrington, Robert A.; Kovacs, Richard; Sliwa, Karen; Medicine, School of MedicineAlthough the attention of the world and the global health community specifically is deservedly focused on the COVID-19 pandemic, other determinants of health continue to have large impacts and may also interact with COVID-19. Air pollution is one crucial example. Established evidence from other respiratory viruses and emerging evidence for COVID-19 specifically indicates that air pollution alters respiratory defense mechanisms leading to worsened infection severity. Air pollution also contributes to co-morbidities that are known to worsen outcomes amongst those infected with COVID-19, and air pollution may also enhance infection transmission due to its impact on more frequent coughing. Yet despite the massive disruption of the COVID-19 pandemic, there are reasons for optimism: broad societal lockdowns have shown us a glimpse of what a future with strong air pollution measures could yield. Thus, the urgency to combat air pollution is not diminished, but instead heightened in the context of the pandemic.Item Taking a Stand Against Air Pollution—The Impact on Cardiovascular Disease(Elsevier, 2021) Brauer, Michael; Casadei, Barbara; Harrington, Robert A.; Kovacs, Richard; Sliwa, Karen; Medicine, School of MedicineAlthough the attention of the world and the global health community specifically is deservedly focused on the COVID-19 pandemic, other determinants of health continue to have large impacts and may also interact with COVID-19. Air pollution is one crucial example. Established evidence from other respiratory viruses and emerging evidence for COVID-19 specifically indicates that air pollution alters respiratory defense mechanisms leading to worsened infection severity. Air pollution also contributes to co-morbidities that are known to worsen outcomes amongst those infected with COVID-19, and air pollution may also enhance infection transmission due to its impact on more frequent coughing. Yet despite the massive disruption of the COVID-19 pandemic, there are reasons for optimism: broad societal lockdowns have shown us a glimpse of what a future with strong air pollution measures could yield. Thus, the urgency to combat air pollution is not diminished, but instead heightened in the context of the pandemic.Item Using Clinical Data Repositories to Assess the Clinical and Financial Burden of Disease: The Example of Mitral Regurgitation(OMICS, 2017) Khemka, Abhishek; Gradus-Pizlo, Irmina; Kovacs, Richard; Tu, Wanzhu; Hayden, Ross; Masud, Abdullah A.; Eckert, George J.; Tierney, William M.; Biostatistics, School of Public HealthAlthough there have been tremendous advances in understanding various disease outcomes, there are significant gaps and the associated costs to investigate disease burden can be exorbitant. Clinical data repositories can be a valuable aid for analysing patient and disease characteristics in a faster and most cost-effective manner. We offer our own example, using mitral regurgitation as the illustration of a disease process that was identified through the use of a clinical data repository in a subset of patients, matched with a control population, and then analysed for clinical and financial factors. Increasing adoption of digital systems to store and analyse large volumes of data paired with incentives by the government and various health systems makes the current environment ripe for an explosion of big data to help guide clinical decision making.