Atrial FibrillationNCT02268799
High Sensitivity Troponin T Levels Following DC Cardioversion for Atrial Fibrillation / Atrial Flutter
An observational study of Atrial Fibrillation and Atrial Flutter, run by University of Limerick at 1 site in Ireland.
Trial summary
The purpose of this study is to determine if there is a rise in serum high sensitivity troponin T (a marker for heart muscle injury) following a direct current cardioversion (shock therapy) used for patients with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- How many people
- 101 participants
- Where
- 1 siteIreland
- Study dates
- Oct 2014to Aug 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atrial fibrillation/flutter who attend the Coronary Care Unit of the University Hospital Limerick for a pre-organised appointment for direct current external cardioversion will be requested to participate in the study
Who may be able to join
- Patients with atrial fibrillation / atrial flutter attending for direct current external cardioversion
- Age 18 or older
Who cannot join
- Myocardial infarction within the last 6 weeks
- Coronary artery bypass grafting, percutaneous coronary intervention or any other invasive cardiac procedure within the last 6 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Sensitivity Troponin T Levels Following Elective External Direct Current Cardioversion for Atrial Fibrillation / Atrial Flutter
The purpose of this study is to determine if there is a rise in serum high sensitivity troponin T (a marker for heart muscle injury) following a direct current cardioversion (shock therapy) used for patients with atrial fibrillation. This will help us determine if direct current cardioversion results in damage to the heart muscles in a sufficient amount to cause a rise in high sensitivity troponin T.
Read the detailed description
High sensitivity Troponin T is a relatively new biomarker that is highly sensitive and specific for myocardial injury. Its widespread use has helped in the determination and investigation for myocardial ischemia in patients. Previous studies have shown a rise in creatine kinase (CK) and the more specific creatine kinase-MB isoenzyme (CKMB) after DC cardioversion. Studies on the earlier generation troponin T found that the levels don't rise or rise only minimally after DC cardioversion. The high sensitivity troponin T has never been studied in the setting of DC cardioversion.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Keywords
- Cardioversion, High Sensitivity Troponin T (Hs-Trop T), Brain Natriuretic Peptide (BNP), Neutrophil Gelatinase-associated Lipocalin (NGAL)
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DC Cardioversion | Patients undergoing DC cardioversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Sensitivity Troponin T levels pre and 6 hours post cardioversion
Measured: 1 year
Secondary outcomes (3)
Creatine Kinase levels pre and 6 hours post cardioversion
Measured: 1 year
B-type Natriuretic Peptide (BNP) levels pre and 6 hours post cardioversion
Measured: 1 year
Neutrophil Gelatinase-associated Lipocalin (NGAL) levels pre and 6 hours post cardioversion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionAug 2015
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronstan Lobo, MB, BMedSc, MRCPI, MRCP(UK), University of Limerick
- Investigators
- Thomas J Kiernan, MD, Study chair, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268799
- Sponsor's protocol ID
- RL002
- Status last verified
- Aug 2015
- First submitted
- 15 Oct 2014
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Sensitivity Troponin T Levels Following Elective External Direct Current Cardioversion for Atrial Fibrillation / Atrial Flutter
- ClinicalTrials.gov ID
- NCT02268799
- Acronym / sponsor ID
- RL002
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Keywords
- Cardioversion, High Sensitivity Troponin T (Hs-Trop T), Brain Natriuretic Peptide (BNP), Neutrophil Gelatinase-associated Lipocalin (NGAL)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Oct 2014 (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 determine if there is a rise in serum high sensitivity troponin T (a marker for heart muscle injury) following a direct current cardioversion (shock therapy) used for patients with atrial fibrillation. This will help us determine if direct current cardioversion results in damage to the heart muscles in a sufficient amount to cause a rise in high sensitivity troponin T.
Detailed description
High sensitivity Troponin T is a relatively new biomarker that is highly sensitive and specific for myocardial injury. Its widespread use has helped in the determination and investigation for myocardial ischemia in patients. Previous studies have shown a rise in creatine kinase (CK) and the more specific creatine kinase-MB isoenzyme (CKMB) after DC cardioversion. Studies on the earlier generation troponin T found that the levels don't rise or rise only minimally after DC cardioversion. The high sensitivity troponin T has never been studied in the setting of DC cardioversion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DC Cardioversion | – | –Patients undergoing DC cardioversion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation/flutter who attend the Coronary Care Unit of the University Hospital Limerick for a pre-organised appointment for direct current external cardioversion will be requested to participate in the study
Key inclusion criteria (2 listed)
- Patients with atrial fibrillation / atrial flutter attending for direct current external cardioversion
- Age 18 or older
Key exclusion criteria (2 listed)
- Myocardial infarction within the last 6 weeks
- Coronary artery bypass grafting, percutaneous coronary intervention or any other invasive cardiac procedure within the last 6 weeks
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
High Sensitivity Troponin T levels pre and 6 hours post cardioversion
Time frame: 1 year
3 secondary outcomes
Creatine Kinase levels pre and 6 hours post cardioversion
Time frame: 1 year
B-type Natriuretic Peptide (BNP) levels pre and 6 hours post cardioversion
Time frame: 1 year
Neutrophil Gelatinase-associated Lipocalin (NGAL) levels pre and 6 hours post cardioversion
Time frame: 1 year
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 13 Aug 2015.
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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.
Thomas J Kiernan, MD study chair
University of Limerick
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 and Atrial Flutter, run by University of Limerick at 1 site in Ireland.
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 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: finished, as of the sponsor's last update on 13 Aug 2015. 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 Ireland. 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?
High Sensitivity Troponin T levels pre and 6 hours post cardioversion (time frame: 1 year). 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 13 Aug 2015.