Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design

<p>Abstract</p> <p>Background</p> <p>Several studies have shown an association of cryptogenic stroke and embolism with patent foramen ovale (PFO), but the question how to prevent further events in such patients is unresolved. Options include antithrombotic treatment with warfarin or antiplatelet agents or surgical or endovascular closure of the PFO. The PC-Trial was set up to compare endovascular closure and best medical treatment for prevention of recurrent events.</p> <p>Methods</p> <p>The PC-Trial is a randomized clinical trial comparing the efficacy of percutaneous closure of the PFO using the Amplatzer PFO occluder with best medical treatment in patients with cryptogenic embolism, i.e. mostly cryptogenic stroke. Warfarin for 6 months followed by antiplatelet agents is recommended as medical treatment. Randomization is stratified according to patients age (<45 versus ≥45 years), presence of atrial septal aneurysm (ASA yes or no) and number of embolic events before randomization (one versus more than one event). Primary endpoints are death, nonfatal stroke and peripheral embolism.</p> <p>Discussion</p> <p>patients were randomized in 29 centers of Europe, Canada, and Australia. Randomization started February 2000. Enrollment of 414 patients was completed in February 2009. All patients will be followed-up longitudinally. Follow-up is maintained until the last enrolled patient is beyond 2.5 years of follow-up (expected in 2011).</p> <p>Trial Registration</p> <p>Trial listed in ClinicalTrials.gov as <a href="http://www.clinicaltrials.gov/ct2/show/NCT00166257">NCT00166257</a> and sponsored by AGA Medical, Plymouth, MN, USA</p

Avaliação audiológica em funcionários de um hospital público expostos a ruído

Purposeto characterize and to compare the hearing of employees of a public hospital exposed to maximum occupational noise levels above and below 85dB(A). Methodthis clinical study selected 39 workers of a public hospital, divided according to the level of noise exposure: 20 subjects with maximum exposure levels above 85dB(A) (Group 1) and 19 individuals with maximum exposure levels below 85dB(A) (Group 2). Basic audiological evaluation, transient and distortion product otoacoustic emissions were carried out. Resultboth groups presented normal hearing thresholds. However, 87.5% in Group 1 and 60.5% in Group 2 showed absent responses in transient evoked otoacoustic emissions, with statistical difference. Group 2 showed higher signal/noise ratios also in distortion product otoacoustic emissions, and only the frequency of 6 kHz was abnormal in both groups. Conclusionsound pressure levels and noise exposure time did not influence in pure tone thresholds. The higher the sound pressure level and the longer the exposure time, more altered the otoacoustic emissions, indicating cochlear dysfunction.Objetivocaracterizar e comparar a audição de funcionários de um hospital público expostos a níveis de ruído ocupacional máximos superiores e inferiores a 85dB(A). Métodotrata-se de um estudo clínico, com 39 funcionários de um hospital público, divididos de acordo com o nível de exposição ao ruído: 20 indivíduos sob exposição máxima superior a 85dB(A) (Grupo 1) e 19 indivíduos sob exposição máxima inferior a 85dB(A) (Grupo 2). Foi realizada avaliação audiológica básica e emissões otoacústicas evocadas por estímulo transiente e produto de distorção. Resultadoambos os grupos apresentaram limiares de audibilidade normais. Contudo, observou-se ausência de respostas em 87,5% no Grupo 1 e 60,5% no Grupo 2 no teste de emissões otoacústicas evocadas por estímulo transiente, com diferença estatística. O Grupo 1 mostrou menor amplitude de respostas também às emissões otoacústicas produto de distorção, sendo a frequência de 6kHz a única alterada em ambos os grupos. Conclusãoos níveis de pressão sonora e o tempo de exposição não influenciam os limiares auditivos tonais. As emissões otoacústicas mostraram-se mais alteradas quanto maior o nível de pressão sonora e tempo de exposição.Universidade Federal de São Paulo (UNIFESP)Universidade Federal de São Paulo (UNIFESP) Departamento de FonoaudiologiaUNIFESP, Depto. de FonoaudiologiaSciEL