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

17. juli 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

25

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610
        • University of Florida

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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?

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Procedure: 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.
Andre navne:
  • Minimally Invasive Maze Procedure
Aktiv komparator: Medical Therapy
Patients are treated with rhythm and rate control medications.
Andet: Medical therapy
Patients are treated with rhythm and rate control medications.
Andre navne:
  • Medicinsk ledelse

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of Life RAND 36-Item Health Survey
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Florida

Efterforskere

  • Ledende efterforsker: Thomas Beaver, MD, University of Florida

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2010

Primær færdiggørelse (Faktiske)

1. november 2013

Studieafslutning (Faktiske)

1. november 2014

Datoer for studieregistrering

Først indsendt

5. oktober 2010

Først indsendt, der opfyldte QC-kriterier

27. september 2011

Først opslået (Skøn)

28. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. juli 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juli 2015

Sidst verificeret

1. juli 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 433-2009

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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