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

Not Applicable

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Procedure: non-invasive testing

• Registration Number: NCT00745602
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-08-29
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	non-invasive testing	Patients referred for elective direct current cardioversion (DCCV) of atrial fibrillation.

Primary Outcome Measures

Name	Time	Method
to determine whether the irregular effects of atrial fibrillation on the body's circulation directly impacts the regulation of cerebral blood flow	0

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States