Atrial FibrillationNCT00745602
The Effect of Atrial Fibrillation Hemodynamics on Regulation of Cerebral Blood Flow
A study testing non-invasive testing in people with Atrial Fibrillation, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- non-invasive testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects in sinus rhythm without assessment of any prior atrial fibrillation by this research team
- Subjects unable to understand and given informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- non-invasive testing
- Keywords
- direct current cardioversion, cerebral blood flow
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive testingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients referred for elective direct current cardioversion (DCCV) of atrial fibrillation. Receives: Procedure: non-invasive testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine whether the irregular effects of atrial fibrillation on the body's circulation directly impacts the regulation of cerebral blood flow
Measured: 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2009 (estimated)
- Study completionOct 2009 (estimated)
Why it stopped: Could not get funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose A Joglar, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745602
- Sponsor's protocol ID
- UTSW IRB 092007-020
- Status last verified
- Jan 2019
- First submitted
- 29 Aug 2008
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Atrial Fibrillation Hemodynamics on Regulation of Cerebral Blood Flow
- ClinicalTrials.gov ID
- NCT00745602
- Acronym / sponsor ID
- UTSW IRB 092007-020
- Conditions
- Atrial Fibrillation
- Keywords
- direct current cardioversion, cerebral blood flow
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not get funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: non-invasive testingPatients referred for elective direct current cardioversion (DCCV) of atrial fibrillation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects in sinus rhythm without assessment of any prior atrial fibrillation by this research team
- Subjects unable to understand and given informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive testingnon-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 | Procedure or surgery | 1 |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose A Joglar principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive testing in people with Atrial Fibrillation, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.