Atrial FibrillationA-FibNCT00614107
Organization in Acute Atrial Fibrillation Post Open Heart Surgery
An observational study of Atrial Fibrillation, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
A form of irregular heart rate called, Atrial Fibrillation (AF) is a major clinical problem. It afflicts about 2 million Americans and is the single largest heart related cause of stroke. However, despite 120 years of speculation and research, the mechanisms that cause AF are poorly understood. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2009
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any person over 18 years having an elective valve, CABG or combination procedure
Who may be able to join
- 18 years of age, Male or Female
- Able to provide consent
- Cardiac surgery, CABG of Valve replacement or repair.
Who cannot join
- If AF terminates within 1 hour of initiation.
- If the patient undergoes electrical cardioversion and/or receives digitalis within the first hour of inclusion.
- If the patients and/or their family or the primary caregiver choose to be excluded from the study anytime, even after the initial 24-hour period.
- If the patient expires within 1 hour of inclusion into the study. -
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
A form of irregular heart rate called, Atrial Fibrillation (AF) is a major clinical problem. It afflicts about 2 million Americans and is the single largest heart related cause of stroke. However, despite 120 years of speculation and research, the mechanisms that cause AF are poorly understood. Acute AF is also the most common irregular heart rate after open-heart surgery in patients. This is seen in as many as 30% of such patients and often results in a longer hospital stay.
In this study we would like to study the pattern of atrial fibrosis (scar tissue in the heart) and an associated blood marker (a protein called pro-collagen-1) in those patients concurrently having open heart surgery.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation post open heart surgery
- Medical subject headings
- Atrial Fibrillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionJan 2009
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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614107
- Sponsor's protocol ID
- 5301UMU
- Acronym
- A-Fib
- Status last verified
- Jan 2008
- First submitted
- 30 Jan 2008
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organization in Acute Atrial Fibrillation Post Open Heart Surgery
- ClinicalTrials.gov ID
- NCT00614107
- Acronym / sponsor ID
- A-Fib / 5301UMU
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation post open heart surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 13 Feb 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.
A form of irregular heart rate called, Atrial Fibrillation (AF) is a major clinical problem. It afflicts about 2 million Americans and is the single largest heart related cause of stroke. However, despite 120 years of speculation and research, the mechanisms that cause AF are poorly understood. Acute AF is also the most common irregular heart rate after open-heart surgery in patients. This is seen in as many as 30% of such patients and often results in a longer hospital stay.
In this study we would like to study the pattern of atrial fibrosis (scar tissue in the heart) and an associated blood marker (a protein called pro-collagen-1) in those patients concurrently having open heart surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any person over 18 years having an elective valve, CABG or combination procedure
Key inclusion criteria (3 listed)
- 18 years of age, Male or Female
- Able to provide consent
- Cardiac surgery, CABG of Valve replacement or repair.
Key exclusion criteria (4 listed)
- If AF terminates within 1 hour of initiation.
- If the patient undergoes electrical cardioversion and/or receives digitalis within the first hour of inclusion.
- If the patients and/or their family or the primary caregiver choose to be excluded from the study anytime, even after the initial 24-hour period.
- If the patient expires within 1 hour of inclusion into the study. -
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
Not reported in the source record.
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 20 Oct 2021.
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Atrial Fibrillation (AF)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 State University of New York - Upstate Medical 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 3 inclusion and 4 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 20 Oct 2021. 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.
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 20 Oct 2021.