Atrial FibrillationDCCVNCT00885391
QT Variability Pre and Post Cardioversion
An observational study of Atrial Fibrillation, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to learn whether the chemicals in the blood and urine are different when the heart is atrial fibrillation compared to normal sinus rhythm. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Mar 2012
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiology Clinic Hospital inpatient
Who may be able to join
- At least 21 years of age
- Scheduled to undergo an elective DC-Cardioversion of atrial fibrillation or atrial flutter at Vanderbilt University Medical Center
Who cannot join
- Undergoing emergent DC-Cardioversion of atrial fibrillation for hemodynamic instability
- Undergoing DC-Cardioversion for post-cardiac surgery
- Dual chamber pacemakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-0575
About this study
Official title: QT Variability Pre & Post Cardioversion in Patient's With Atrial Fibrillation
The purpose of this study is to learn whether the chemicals in the blood and urine are different when the heart is atrial fibrillation compared to normal sinus rhythm.
Read the detailed description
Atrial Fibrillation variably activates the renin-angiotensin-aldosterone system (RAAS), stimulates the sympathetic nervous system, generates oxidant stress, produces natriuretic peptides, and increases ventricular rate. These are interrelated responses and the extent to which these or other pathophysiologic responses determine QT interval during and after Atrial Fibrillation (AF) is unknown. In this study, the QT variability is related to those potential markers in patients with AF undergoing elective DC-cardioversion.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Cardioversion, Direct Current Cardioversion, QT Interval
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
QT variability before and after direct current cardioversion
Measured: 1.5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startJan 2007
- Primary completionMar 2012
- Study completionMar 2012
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Wake Forest University Health Sciences
- Responsible party
- Principal investigator, Dawood Darbar, Vanderbilt University
- Investigators
- Dawood Darbar, M.D., Ph.D., F.A.C.C., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885391
- Sponsor's protocol ID
- 060908
- Other IDs
- R01HL085690-01A2
- Acronym
- DCCV
- Status last verified
- Dec 2014
- First submitted
- 20 Apr 2009
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QT Variability Pre & Post Cardioversion in Patient's With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00885391
- Acronym / sponsor ID
- DCCV / 060908
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Cardioversion, Direct Current Cardioversion, QT Interval
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Wake Forest University Health Sciences
- Study start
- Jan 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 Apr 2009 (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 purpose of this study is to learn whether the chemicals in the blood and urine are different when the heart is atrial fibrillation compared to normal sinus rhythm.
Detailed description
Atrial Fibrillation variably activates the renin-angiotensin-aldosterone system (RAAS), stimulates the sympathetic nervous system, generates oxidant stress, produces natriuretic peptides, and increases ventricular rate. These are interrelated responses and the extent to which these or other pathophysiologic responses determine QT interval during and after Atrial Fibrillation (AF) is unknown. In this study, the QT variability is related to those potential markers in patients with AF undergoing elective DC-cardioversion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiology Clinic Hospital inpatient
Key inclusion criteria (2 listed)
- At least 21 years of age
- Scheduled to undergo an elective DC-Cardioversion of atrial fibrillation or atrial flutter at Vanderbilt University Medical Center
Key exclusion criteria (3 listed)
- Undergoing emergent DC-Cardioversion of atrial fibrillation for hemodynamic instability
- Undergoing DC-Cardioversion for post-cardiac surgery
- Dual chamber pacemakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
QT variability before and after direct current cardioversion
Time frame: 1.5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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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.
Dawood Darbar, M.D., Ph.D., F.A.C.C. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Vanderbilt University 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 11 Dec 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
QT variability before and after direct current cardioversion (time frame: 1.5). 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 11 Dec 2014.