Atrial FibrillationNCT01493128
Ultrastructure of Atrial Myocytes in Patients in Sinus Rhythm and With Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Norwegian University of Science and Technology.
Trial summary
The aim of this work is to study the prevalence of T-tubular system in left and right myocytes from patients in sinus rhythm and whether this is altered in paroxysmal and permanent atrial fibrillation. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Jul 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: selected for open heart surgery in St Olavs Hospital, Trondheim University Hospital, Norway
Who may be able to join
- sinus rhythm, permanent atrial fibrillation or paroxysmal atrial fibrillation
- selected for open heart surgery
- informed consent
Who cannot join
- not given informed consent
About this study
Official title: Ultrastructure of Sarcolemma, Immunofluorescence of Calcium Handling Proteins and Mitochondrial Function in Atrial Myocytes of Patients in Sinus Rhythm and With Atrial Fibrillation
The aim of this work is to study the prevalence of T-tubular system in left and right myocytes from patients in sinus rhythm and whether this is altered in paroxysmal and permanent atrial fibrillation. Furthermore, since current information is lacking on the key Ca2+-handling proteins RyR, NCX, and SERCA-2a from patients in Atrial Fibrillation (AF), it will be investigated whether a regulation of these proteins could be an underlying cause of the disease. Mitochondrial function will also studied.
- The investigators hypothesize that both structure of sarcolemma and localization of key Ca2+-handling proteins are altered in patients with atrial fibrillation compared with patients in sinus rhythm.
- The investigators hypothesize that mitochondrial function is altered in patients with atrial fibrillation compared with patients in sinus rhythm.
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, atrial cells, myocardial tissue, t-tubules, immunofluorescence
- Medical subject headings
- Atrial Fibrillation
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 |
|---|---|---|
| stable sinus rhythm | Not described | |
| permanent atrial fibrillation | Not described | |
| paroxysmal atrial fibrillation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
structure of sarcolemma
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startApr 2010
- Primary completionFeb 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrik Wisløff, PhD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493128
- Sponsor's protocol ID
- ABJ01
- Status last verified
- Mar 2017
- First submitted
- 13 Dec 2011
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Slagsvold KH, Johnsen AB, Rognmo O, Hoydal MA, Wisloff U, Wahba A. Mitochondrial respiration and microRNA expression in right and left atrium of patients with atrial fibrillation. Physiol Genomics. 2014 Jul 15;46(14):505-11. doi: 10.1152/physiolgenomics.00042.2014. Epub 2014 May 13.
PubMed 24824214
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrastructure of Sarcolemma, Immunofluorescence of Calcium Handling Proteins and Mitochondrial Function in Atrial Myocytes of Patients in Sinus Rhythm and With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01493128
- Acronym / sponsor ID
- ABJ01
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, atrial cells, myocardial tissue, t-tubules, immunofluorescence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 Dec 2011 (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 aim of this work is to study the prevalence of T-tubular system in left and right myocytes from patients in sinus rhythm and whether this is altered in paroxysmal and permanent atrial fibrillation. Furthermore, since current information is lacking on the key Ca2+-handling proteins RyR, NCX, and SERCA-2a from patients in Atrial Fibrillation (AF), it will be investigated whether a regulation of these proteins could be an underlying cause of the disease. Mitochondrial function will also studied.
- The investigators hypothesize that both structure of sarcolemma and localization of key Ca2+-handling proteins are altered in patients with atrial fibrillation compared with patients in sinus rhythm.
- The investigators hypothesize that mitochondrial function is altered in patients with atrial fibrillation compared with patients in sinus rhythm.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| stable sinus rhythm | – | – |
| permanent atrial fibrillation | – | – |
| paroxysmal atrial fibrillation | – | – |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- selected for open heart surgery in St Olavs Hospital, Trondheim University Hospital, Norway
Key inclusion criteria (3 listed)
- sinus rhythm, permanent atrial fibrillation or paroxysmal atrial fibrillation
- selected for open heart surgery
- informed consent
Key exclusion criteria (1 listed)
- not 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.
Primary outcome
structure of sarcolemma
Time frame: 1 hour
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 Mar 2017.
- Results publication: PubMed 24824214Slagsvold KH, Johnsen AB, Rognmo O, Hoydal MA, Wisloff U, Wahba A. Mitochondrial respiration and microRNA expression in right and left atrium of patients with atrial fibrillation. Physiol Genomics. 2014 Jul 15;46(14):505-11. doi: 10.1152/physiolgenomics.00042.2014. Epub 2014 May 13.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Ulrik Wisløff, PhD study director
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Norwegian University of Science and Technology.
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 1 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 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
structure of sarcolemma (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01493128, which also lists 1 linked publication.
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 Mar 2017.