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

17 luglio 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Effettivo)

25

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Florida
      • Gainesville, Florida, Stati Uniti, 32610
        • University of Florida

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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?

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Procedura: 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.
Altri nomi:
  • Minimally Invasive Maze Procedure
Comparatore attivo: Medical Therapy
Patients are treated with rhythm and rate control medications.
Altro: Medical therapy
Patients are treated with rhythm and rate control medications.
Altri nomi:
  • Gestione medica

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of Life RAND 36-Item Health Survey
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Florida

Investigatori

  • Investigatore principale: Thomas Beaver, MD, University of Florida

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2010

Completamento primario (Effettivo)

1 novembre 2013

Completamento dello studio (Effettivo)

1 novembre 2014

Date di iscrizione allo studio

Primo inviato

5 ottobre 2010

Primo inviato che soddisfa i criteri di controllo qualità

27 settembre 2011

Primo Inserito (Stima)

28 settembre 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

23 luglio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 luglio 2015

Ultimo verificato

1 luglio 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 433-2009

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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