Atrial FibrillationPhase 1NCT00289367
Study of T3 on the Incidence of Atrial Fibrillation in Patients Undergoing Cardiac Surgery
A Phase 1 study testing Triiodothyronine in people with Atrial Fibrillation, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this project is to see whether treatment with a thyroid hormone, called triiodothyronine or T3, following open heart surgery reduces the risk of developing atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Triiodothyronine
- Type of treatment
- Injection or infusion
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to May 2008
- Phase
- Phase 1
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring CABG or valve repair/replacement surgery.
- Patient must be able to provide informed consent.
Who cannot join
- Patients less than 18 or over 85 years of age.
- Patients less than 50kg or greater than 120kg.
- Patients currently with endocrine disorders, excluding diabetes.
- Patients currently with thyroid dysfunction (e.g., hyper- hyperthyroidism, goiter, Grave's disease), myxedema, or myxedema coma, even if treated.
- Patients currently receiving thyroid replacement therapy.
- Patients currently receiving Ketamine, levarterenol or dietary (non-food) iodine supplementation.
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- Patients who have received any investigational drugs within the previous one month or five half-lives of the drug.
- Patients who are pregnant. Pregnancy testing will be done for women of child-bearing potential.
- Patients currently in atrial fibrillation.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore University Hospital
Manhasset, New York, 11030
About this study
Official title: Randomized Prospective Study of T3 on the Incidence of Post-Operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
The purpose of this project is to see whether treatment with a thyroid hormone, called triiodothyronine or T3, following open heart surgery reduces the risk of developing atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- Triiodothyronine
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriiodothyronineDrug
0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.
triiodothyronineDrug
IV formulation - Triostat, 0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of atrial fibrillation
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionAug 2006
- Study completionMay 2008
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 Northwell HealthThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas and Jeanne Elmezzi Foundation
- Investigators
- Irwin Klein, MD, Principal investigator, North Shore University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289367
- Sponsor's protocol ID
- 05-075
- Status last verified
- May 2008
- First submitted
- 7 Feb 2006
- Last updated
- 20 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study of T3 on the Incidence of Post-Operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00289367
- Acronym / sponsor ID
- 05-075
- Conditions
- Atrial Fibrillation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Thomas and Jeanne Elmezzi Foundation
- Study start
- Feb 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 9 Feb 2006 (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 project is to see whether treatment with a thyroid hormone, called triiodothyronine or T3, following open heart surgery reduces the risk of developing atrial fibrillation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients requiring CABG or valve repair/replacement surgery.
- Patient must be able to provide informed consent.
Key exclusion criteria (9 listed)
- Patients less than 18 or over 85 years of age.
- Patients less than 50kg or greater than 120kg.
- Patients currently with endocrine disorders, excluding diabetes.
- Patients currently with thyroid dysfunction (e.g., hyper- hyperthyroidism, goiter, Grave's disease), myxedema, or myxedema coma, even if treated.
- Patients currently receiving thyroid replacement therapy.
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 |
|---|---|---|
| Triiodothyronine0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr. | Drug | – |
| triiodothyronineIV formulation - Triostat, 0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr. | Drug | – |
Primary outcome
incidence of atrial fibrillation
Time frame: during hospitalization
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 May 2008.
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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.
Irwin Klein, MD principal investigator
North Shore University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Triiodothyronine in people with Atrial Fibrillation, run by Northwell Health 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 9 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 May 2008. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
incidence of atrial fibrillation (time frame: during hospitalization). 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 20 May 2008.