scholarly journals Prospective long-term follow-up analysis of the cardiovascular system in marathon runners: study design of the Pro-MagIC study

2020 ◽  
Vol 6 (1) ◽  
pp. e000786
Author(s):  
Julia Schoenfeld ◽  
Michael Johannes Schindler ◽  
Bernhard Haller ◽  
Stefan Holdenrieder ◽  
David Christopher Nieman ◽  
...  

IntroductionProlonged strenuous exercise training may result in structural, functional and electrical cardiac remodelling, as well as vascular and myocardial injuries. However, the extent to which high-volume, intense exercise is associated with arrhythmias, myocardial fibrosis, coronary heart disease and pathological alterations of the vasculature remains unknown. In addition, there is no clear consensus on the clinical significance of these exercise-induced changes. Previous studies typically used cross-sectional designs and examined exercise-induced cardiovascular changes in small cohorts of athletes for up to 3–7 days of recovery. Long-term longitudinal studies investigating cardiovascular changes induced by prolonged strenuous exercise in large cohorts of athletes are needed to improve scientific understanding in this area.Methods and analysisIn this prospective observational monocenter study, 277 participants of the Beer, Marathon, Genetics, Inflammation and the Cardiovascular System (Be-MaGIC) study (ClinicalTrials.gov: NCT00933218) will be invited to participate in this 10-year follow-up study. A minimum target sample size of 130 participants will be included in the study. Participating athletes will be examined via the following: anthropometry, resting electrocardiography and echocardiography, blood sampling, retinal vessel diameters, carotid sonography and cardiopulmonary exercise testing, including exercise electrocardiography.DiscussionThis longitudinal study will provide comprehensive data on physiological changes in the cardiovascular system and the development of pathologies after a 10-year period of prolonged and strenuous endurance exercise. Since the participants will have engaged in a wide range of training loads and competitive race events, this study will provide useful risk factor determinants and training load cut-off values. The primary endpoint is the association between the exercise-induced increase in cardiac troponin during the Munich marathon 2009 and the decline in right ventricular ejection fraction over the next 10 years.Trial registration numberNCT04166903.

2016 ◽  
Vol 101 (7) ◽  
pp. 811-820
Author(s):  
Gustavo Barbosa dos Santos ◽  
André Gustavo de Oliveira ◽  
Luiz Alberto Ferreira Ramos ◽  
Maria Cristina Cintra Gomes-Marcondes ◽  
Miguel Arcanjo Areas

Author(s):  
Jessica Salley Riccardi ◽  
Libby Crook ◽  
Brenda Eagan-Johnson ◽  
Monica Vaccaro ◽  
Angela H. Ciccia

Purpose: The purpose of this study was to inform school-based services for children with acquired brain injury (ABI) by describing and analyzing functional student-outcome data from a state-wide, school-based, school re-entry consultation program, BrainSTEPS (Strategies Teaching Educators, Parents, and Students), in Pennsylvania. Method: A nonexperimental, retrospective analysis was conducted with data collected during a pilot follow-up survey for BrainSTEPS. Caregivers reported on 337 students with ABI participating in BrainSTEPS. Results: Most students post-ABI who were participating in BrainSTEPS were enrolled in regular education and reported no ongoing symptoms, as well as no parent perception of need for additional BrainSTEPS consultation during the time period of the follow-up survey. Current receipt of therapy was significantly associated with injury type, χ 2 (1, n = 329) = 16.72, p < .001. A multiple logistic regression was significant ( p < .001) in predicting the need for additional BrainSTEPS consultation. More severe injuries, educational placement postinjury of regular education with a 504 plan (compared to regular education), and current receipt of therapy significantly increased the odds of need for consultation. Conclusions: Due to the wide range of experiences of students in this sample, hospital-to-school transition services, educational supports and services, and long-term follow-up must be individualized for children with ABI. Speech-language pathologists are critical members of the school-based academic team for students with ABI to decrease long-term unmet needs.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Thomsen ◽  
S Pedersen ◽  
P K Jacobsen ◽  
H V Huikuri ◽  
P E Bloch Thomsen ◽  
...  

Abstract Introduction The CARISMA trial was the first study to use continuous monitoring for documentation of long-term arrhythmias in post-infarction patients with left ventricular dysfunction. During the study duration (2000–2005), primary PCI (pPCI) as treatment of acute myocardial infarction was introduced approximately midway (2002) on the enrolling centres. Purpose The aim of this study was to describe the influence of mode of revascularization after myocardial infarction (AMI) on long-term risk of risk of new onset atrial fibrillation, ventricular tachyarrhythmias and brady arrhythmias. Methods The study is a sub-study on the CARISMA study population that consisted of patients with AMI and left ventricular ejection fraction ≤40%, which received an implantable loop recorder and was followed for 2 years. After exclusion of 15 patients who refused device implantation and 26 with pre-existing arrhythmias, 268 of the 312 patients were included. Choice of revascularization was made by the treating team independently of the trial and was retrospectively divided into primary percutaneous intervention (pPCI), subacute PCI (24 hours to 2 weeks after AMI), primary thrombolysis or no revascularization. Endpoints were new-onset of arrhythmias and major cardiovascular events (MACE). The Kaplan-Meier (figure 1) and Mantel-Byar methods were used for time to first event risk analysis. Results A total of 77 patients received no revascularization, whereas 49 received thrombolysis only and 142 received PCI. At two-years follow up patients treated with any PCI had a significant lower risk (0.40, n=63) of any arrhythmia compared to patients treated with trombolysis (0.60, n=30) or no revascularization (0.68, n=16) (p<0.001, unadjusted) (figure 1). Risk of MACE was significant higher in patients with any arrhythmia (0.25, n=76) compared to no arrhythmia (0.11, n=93) at two years follow-up (p=0.004, unadjusted). Figure 1 Conclusion(s) The long-term risk of new onset arrhythmias after AMI was significantly lower in patients treated with any PCI compared to patients not revascularized or treated with thrombolysis. Risk of MACE was significantly higher in patients with new onset arrhythmias compared to patients with no arrhythmias.


2021 ◽  
Vol 94 (1117) ◽  
pp. 20201041
Author(s):  
Keerti Sitani ◽  
Rahul V Parghane ◽  
Sanjay Talole ◽  
Sandip Basu

Objectives: Assessment of long-term outcome and toxicity of indigenous 177Lu-DOTATATE PRRT in patients of metastatic/advanced NETs in a large tertiary-care PRRT setting. Methods: A total of 468 metastatic/advanced NET patients (wide range of primary sites including CUP-NETs), who underwent at least two cycles of 177Lu-DOTATATE PRRT with available follow-up information, were included and analysed retrospectively in this study. In-house labelling of DOTATATE with 177Lu (direct route produced) was carried out in the hospital radiopharmacy and treatment administered in cycles (dose: 5.55 to 7.4 GBq per patient), at 10–12 weeks interval. The assessment of long-term outcome was undertaken under three broad headings: (a) Therapeutic response, (b) Survival outcome and (c) Toxicity assessment. The median point estimate with 95% CI for progression free survival (PFS) and overall survival (OS) were calculated by Kaplan–Meier method. Prognostic covariates for association with PFS and OS was investigated by Cox proportional hazards model (univariate and multivariate Hazard Ratios) and with disease control rate (DCR) by Chi-square test, with significant P value defined as <0.05. Results: Long-term outcome (follow-up ranging from 4 to 97.6 months; median period:46 months following first 177Lu-DOTATATE PRRT) results showed, (i) on symptomatic response evaluation scale, complete response (CR) in 214 patients (45.7%), partial response (PR) in 108 (23.1%), stable disease (SD) in 118 (25.2%), progressive disease (PD) in 28 (6%). (ii) Biochemical response evaluation showed CR in 52 (12%), PR in 172 (40%), SD in 161 (38%), and PD in 42 patients (10%). (iii) Molecular imaging response (by PERCIST criteria) showed CR in 29 (6%), PR in 116 (25%), SD in 267 (57%) and PD in 56 (12%) patients. (iv) On RECIST 1.1 criteria, CR was observed in 14 patients (3%), PR in 126 patients (27%), SD in 282 patients (60%) and PD in 46 patients (10%). The median PFS and OS were not reached at a median follow-up of 46 months. Observed PFS and OS at 7 years were 71.1% 95% CI (62.4–79.7%) and 79.4% 95% CI (71.4–86.9%) respectively. PFS was dependent on previous history of chemotherapy, baseline 68Ga-DOTATATE and 18F-FDG uptake, site of primary tumour, total cumulative dose and number of PRRT cycles on univariate analysis, whereas multivariate analysis showed significant association for previous history of chemotherapy, baseline 68Ga-DOTATATE and 18F-FDG uptake and number of PRRT cycles. The OS was dependent on baseline 68Ga-DOTATATE uptake, site of primary tumour, presence of bony metastatic disease, total cumulative dose and number of PRRT cycles on univariate analysis, whereas multivariate analysis showed significant association for bony metastatic disease and number of PRRT cycles. Transient haematological toxicity of Grade 1, Grade 2, and Grade 3 was found in 8 (1.7%), 1 (0.2%) and one patient (0.2%), respectively. Nephrotoxicity of Grade 1, Grade 2, Grade 3, and Grade 4 were seen in 16 (3.5%), 3 (0.6%), 2 (0.4%) and one patient (0.2%), respectively. On a separate sub-analysis of 322 NET patients with progressive disease at the initiation point of PRRT, overall response rates (CR + PR + SD) were 93.5%, 88.5%, 89.1 and 87.9% on symptomatic, biochemical, RECIST 1.1 and PERCIST criteria and PFS and OS at 7 years 68.3% and 79.2%, respectively. Conclusions: The present results demonstrate that 177Lu-DOTATATE PRRT improved symptoms and biochemical markers substantially in most of the NET patients, with disease stabilisation on both anatomical and molecular imaging in majority and response in a sizeable fraction. Additionally, the therapeutic protocol with lesser dose per cycle (mean 5.92 GBq/cycle) and prolonged duration (over 5 cycles and 1.5 years) in a metastatic NET setting proved equally efficacious (with superior PFS and OS rates) and relatively better tolerated with minimal toxicity. Advances in knowledge: The present work critically examines the long-term results, survival outcome and toxicity profile of the indigenous 177Lu-DOTATATE (produced through direct neutron activation of enriched 176Lu) in metastatic progressive NETs across a wide range of primary sites and malignancies. Such long-term outcome data establishes the favourable impact of PRRT in a wide patient base and also the therapeutic efficacy of the product.


2018 ◽  
Vol 34 (7) ◽  
Author(s):  
Juliana Lustosa Torres ◽  
Erico Castro-Costa ◽  
Juliana Vaz de Melo Mambrini ◽  
Sérgio William Viana Peixoto ◽  
Breno Satler de Oliveira Diniz ◽  
...  

Psychosocial factors appear to be associated with increased risk of disability in later life. However, there is a lack of evidence based on long-term longitudinal data from Western low-middle income countries. We investigated whether psychosocial factors at baseline predict new-onset disability in long term in a population-based cohort of older Brazilians adults. We used 15-year follow-up data from 1,014 participants aged 60 years and older of the Bambuí (Brazil) Cohort Study of Aging. Limitations on activities of daily living (ADL) were measured annually, comprising 9,252 measures. Psychosocial factors included depressive symptoms, social support and social network. Potential covariates included sociodemographic characteristics, lifestyle, cognitive function and a physical health score based on 10 self-reported and objectively measured medical conditions. Statistical analysis was based on competitive-risk framework, having death as the competing risk event. Baseline depressive symptoms and emotional support from the closest person were both associated with future ADL disability, independently of potential covariates wide range. The findings showed a clear graded association, in that the risk gradually increased from low emotional support alone (sub-hazard ratio - SHR = 1.11; 95%CI: 1.01; 1.45) to depressive symptoms alone (SHR = 1.52; 95%CI: 1.13; 2.01) and then to both factors combined (SHR = 1.61; 95%CI: 1.18; 2.18). Marital status and social network size were not associated with incident disability. In a population of older Brazilian adults, lower emotional support and depressive symptoms have independent predictive value for subsequent disability in very long term.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
P Simonen ◽  
J Lehtonen ◽  
M Kupari

Abstract Background Sarcoidosis is characterized by the formation of inflammatory epithelioid-cell granulomas in various organs with cardiac involvement as its most ominous manifestation. A female preponderance in the prevalence of cardiac sarcoidosis (CS) is well known but other possible gender differences remain poorly studied. Purpose We set out to evaluate gender-related differences in the manifestations and long-term outcome of CS. Methods We reviewed the history, diagnostic procedures, details of treatment and outcome of 158 consecutive patients with histologically confirmed CS diagnosis between 1988 and 2017 at our hospital. Follow-up data were collected up to the end of 2018. Results The study population consisted of 51 men and 107 women (68%). At presentation, men were younger than women (mean age 47 years vs 51 years, p=0.045) and had more often a history of pre-existing extracardiac sarcoidosis (25% vs 10%, p=0.013). Isolated CS remained less common in men even after the complete diagnostic process (50% vs 75%, p=0.001). The main presenting CS manifestations were atrioventricular block, ventricular tachyarrhythmias and heart failure in 39%, 30% and 18% of men vs in 54%, 23% and 17% of women, respectively (p=0.183). Left ventricular ejection fraction at presentation averaged 49±11% in men and 49±13% in women (p=0.845). Troponin T was elevated more often in men at the presentation (46% vs 26%, p=0.024). At magnetic resonance imaging, pathological myocardial late gadolinium enhancement was observed in 87% of men and 84% of women (p=0.615). Myocardial “hot spot” at 18-F fluorodeoxyglucose positron emission tomography was also equally common (87% in men, 92% in women, p=0.468). An intracardiac cardioverter-defibrillator was implanted in 78% of men and 75% of women (p=0.693) and nearly all patients (99%, no gender difference) received immunosuppressive therapy. During the mean follow-up of 64 months, 10 of 51 men versus 30 of 107 women either died of a cardiac cause, suffered an aborted sudden cardiac death or underwent transplantation. The composite event-free survival did not differ between genders (Figure 1. Log-rank p=0.852). Conclusions Two thirds of CS patients are women. At disease presentation, women are older than men and their sarcoidosis is more often isolated to the heart but the clinical manifestations, diagnostic findings and long-term outcome are comparable in the two genders.


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