Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Florida
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Gainesville, Florida, Forente stater, 32610
- University of Florida
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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.
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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 navn:
|
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Aktiv komparator: Medical Therapy
Patients are treated with rhythm and rate control medications.
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Patients are treated with rhythm and rate control medications.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Thomas Beaver, MD, University of Florida
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 433-2009
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