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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00745602
First received: August 29, 2008
Last updated: February 17, 2010
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention
Atrial Fibrillation
 Procedure: non-invasive testing

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Effect of Atrial Fibrillation Hemodynamics on Regulation of Cerebral Blood Flow

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • to determine whether the irregular effects of atrial fibrillation on the body's circulation directly impacts the regulation of cerebral blood flow [ Time Frame: 0 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2007
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients referred for elective direct current cardioversion (DCCV) of atrial fibrillation.
 Procedure: 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745602

Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Carol Nguyen     214-590-5015     Carol.Nguyen@UTSouthwestern.edu    
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Jose A Joglar UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Jose Joglar, MD, UT Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00745602     History of Changes
Other Study ID Numbers: UTSW IRB 092007-020
Study First Received: August 29, 2008
Last Updated: February 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
direct current cardioversion, cerebral blood flow

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013