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Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation

17 de julho de 2015 atualizado por: University of Florida
The purpose of this study is to compare a minimally invasive surgical procedure and medication management in stroke patients with Atrial Fibrillation. The two treatment options are a minimally invasive surgical procedure or the use of medications.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Must have had a stroke or transient ischemic attack (TIA) and have Atrial Fibrillation

Tipo de estudo

Intervencional

Inscrição (Real)

25

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Florida
      • Gainesville, Florida, Estados Unidos, 32610
        • University of Florida

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Patients with a history of stroke and paroxysmal, persistent or permanent AF.
  • Ischemic stroke or TIA with documented paroxysmal or persistent atrial fibrillation. A TIA will meet inclusion criteria as a sudden-onset focal neurological symptom or sign lasting at least 10 minutes but less than 24 hours with or without evidence of acute brain ischemia on diffusion weighted MRI imaging.
  • Eligible symptoms INCLUDE hemiplegia or hemiparesis, monoplegia, or language disturbance other than isolated dysarthria.
  • Symptoms that will NOT QUALIFY AS TIA INCLUDE transient monocular blindness in both eyes, dysarthria, vertigo,isolated sensory symptoms, confusion, memory loss, nonspecific complaints of dizziness, or syncope.

Exclusion Criteria:

  • Recent stroke (< 1 month).
  • Age < 18 or > 80 years; Ejection Fraction < 25%• Presence of left atrial appendage thrombus on CT or echocardiography
  • Previous empyema or thoracic surgery, preventing access to the pulmonary veins via thoracoscopy.
  • Left Atrial Diameter > 55mm.
  • Contraindication to anticoagulation with Coumadin.
  • Mitral insufficiency (> 2+)
  • • • Contraindications to MRI
  • •Artificial heart valve prosthesis
  • Aneurysm clips
  • Implanted drug infusion device or pump
  • Any type of neurotranstimulator
  • Any type of bone growth stimulator
  • Cochlear implants or inner ear prosthesis
  • Any intravascular coils, filters, or stents
  • Shrapnel or bullets
  • Other metallic implants or devices specify which
  • Permanently tattooed eyeliner
  • Are you pregnant or suspect to be pregnant?

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Minimally Invasive Surgery
Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
Procedimento: Minimally Invasive Surgery
Small thumb sized incisions are made on each side of the chest wall where instruments are inserted for the purpose of completing the surgery.
Outros nomes:
  • Minimally Invasive Maze Procedure
Comparador Ativo: Medical Therapy
Patients are treated with rhythm and rate control medications.
Outro: Medical therapy
Patients are treated with rhythm and rate control medications.
Outros nomes:
  • Gerenciamento médico

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Quality of Life RAND 36-Item Health Survey
Prazo: Change in baseline, 3 month, and 6 month

Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation).

The RAND 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores which will have a 0 to 100 range.
Change in baseline, 3 month, and 6 month

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory)
Prazo: Change in baseline, 3 month, and 6 month
Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Change in baseline, 3 month, and 6 month
STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory)
Prazo: Change in baseline, 3 month, and 6 month
Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Change in baseline, 3 month, and 6 month
Montreal Cognitive Assessment (Moca)
Prazo: Change in baseline, 3 month, and 6 month
Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The score is 0 - 30 point test with the higher the score the better cognitive function.
Change in baseline, 3 month, and 6 month
Directed Fluency; Cowa (Controlled Oral Word Association Test)
Prazo: Change in baseline, 3 month, and 6 month
Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The participant is asked to name as many words as possible beginning with a letter, excluding proper nouns, for one minute and this procedure is repeated three times.
Change in baseline, 3 month, and 6 month
Hopkins Verbal Learning Test Version A
Prazo: Change in baseline, 3 month, and 6 month
Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). This test measures word recognition. 12 words are read to the subject and they have to repeat as many as they can recall. There are 4 trials, each with 12 total possible words.
Change in baseline, 3 month, and 6 month
Stroop Color Test
Prazo: Change in baseline, 3 month, and 6 month

Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Only 9 patients in the minimally invasive surgery arm completed the stroop color test, and only 6 patients in the medical therapy group completed the stroop color test.

In this test, subjects are asked to read a list of color words. 100 is the maximum amount of correct responses per trial.
Change in baseline, 3 month, and 6 month
Wtar (Wechsler Test of Adult Reading) Word List
Prazo: Baseline

Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation).

The WTAR is composed of 50 irregularly spelled words and takes approximately 10 minutes to complete. The examiner begins by presenting the first word card and prompting the patient for a single pronunciation of the word. This procedure continues through all 50 word cards and is discontinued if the patient provides 12 consecutive incorrect pronunciations. Each correct pronunciation is given a score of 1, with 50 as the maximum raw score.
Baseline
Stroop Word Test
Prazo: Change in Baseline, 3 month, and 6 month

Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Only 9 patients in the minimally invasive surgery arm completed the stroop word test, and only 6 patients in the medical therapy group completed the stroop word test.

In this test, subjects are asked to read a list of words. 100 is the maximum amount of correct responses per trial.
Change in Baseline, 3 month, and 6 month
Directed Fluency, Animals
Prazo: Change in Baseline, 3 month, and 6 month
Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The participant is asked to name as many animals as possible beginning with a letter, for one minute.
Change in Baseline, 3 month, and 6 month

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Florida

Investigadores

  • Investigador principal: Thomas Beaver, MD, University of Florida

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de março de 2010

Conclusão Primária (Real)

1 de novembro de 2013

Conclusão do estudo (Real)

1 de novembro de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

5 de outubro de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de setembro de 2011

Primeira postagem (Estimativa)

28 de setembro de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

23 de julho de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de julho de 2015

Última verificação

1 de julho de 2015

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 433-2009

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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