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

Primary Purpose

Atrial Fibrillation

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
non-invasive testing
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring direct current cardioversion, cerebral blood flow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
August 29, 2008
Last Updated
January 7, 2019
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00745602
Brief Title
The Effect of Atrial Fibrillation Hemodynamics on Regulation of Cerebral Blood Flow
Official Title
The Effect of Atrial Fibrillation Hemodynamics on Regulation of Cerebral Blood Flow
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Could not get funding
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
direct current cardioversion, cerebral blood flow

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients referred for elective direct current cardioversion (DCCV) of atrial fibrillation.
Intervention Type
Procedure
Intervention Name(s)
non-invasive testing
Intervention Description
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
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose A Joglar
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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