The Effect of Atrial Fibrillation Hemodynamics on Regulation of Cerebral Blood Flow

NCT ID: NCT00745602

Last Updated: 2019-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-10-31

Brief Summary

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The proposed research will investigate whether the irregular effects of atrial fibrillation on the body's circulation directly impacts the regulation of cerebral blood flow. To further delineate this finding, investigation of these potential effects will include differences in postural positioning. This data will be used to further understand the overall hemodynamic effects of atrial fibrillation on extra-cardiac organs of the body.

Detailed Description

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This is a prospective study evaluating 10 subjects referred for elective direct current cardioversion (DCCV) of atrial fibrillation. Subjects will be seen at Parkland Health and Hospital System.

After full consent is obtained and explanation of the research, each subject will undergo a series of entirely non-invasive tests including Transcranial Doppler ultrasound (TCD), manual cuff blood pressure (BP), beat to beat BP monitoring by a Portapress monitor, and respiratory tidal CO2. These measurements will be taken after laying the patient in a supine position for 10 minutes and subsequently after standing for 10 minutes. Measurements will also be taken after full body squat -stand repetition at 20 second intervals (0.05 Hz) x 5 minutes. Patients who are unable to squat may rise from a seated position on a chair. This protocol has been easy to follow even for debilitated patients with Alzheimers Disease in Dr. Zhang and Dr. Levine's laboratory. The subject will then undergo elective DCCV as planned for standard of care. The above measurements and with respective body positions will then be repeated 30 minutes later if the patient has been successfully converted to normal sinus rhythm by DCCV.

The experimental testing will take approximately 1 ½ to 2 hours to complete.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Patients referred for elective direct current cardioversion (DCCV) of atrial fibrillation.

Group Type EXPERIMENTAL

non-invasive testing

Intervention Type PROCEDURE

non-invasive tests including Transcranial Doppler ultrasound (TCD), manual cuff blood pressure (BP), beat to beat BP monitoring by a Portapress monitor, and respiratory tidal CO2

Interventions

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non-invasive testing

non-invasive tests including Transcranial Doppler ultrasound (TCD), manual cuff blood pressure (BP), beat to beat BP monitoring by a Portapress monitor, and respiratory tidal CO2

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subjects with atrial fibrillation scheduled for DCCV
* Subjects must be at least 18 years of age
* Subjects must have the ability to understand and sign informed consent and be willing to comply with full testing and evaluation

Exclusion Criteria

* Subjects in sinus rhythm without assessment of any prior atrial fibrillation by this research team
* Subjects unable to understand and given informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose A Joglar

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

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UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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UTSW IRB 092007-020

Identifier Type: -

Identifier Source: org_study_id

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