- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00745602
The Effect of Atrial Fibrillation Hemodynamics on Regulation of Cerebral Blood Flow
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75390
- UT Southwestern Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Patients referred for elective direct current cardioversion (DCCV) of atrial fibrillation.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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to determine whether the irregular effects of atrial fibrillation on the body's circulation directly impacts the regulation of cerebral blood flow
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jose A Joglar, UT Southwestern Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UTSW IRB 092007-020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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