Myocardial InjuryTRIMRIPCNCT01308138
Myocardial Physiology And Microanatomy In Individuals Undergoing Heart Surgery
A study testing Exercise training and remote ischemic preconditioning in people with Myocardial Injury, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The main focus of the project is to determine to what degree myocardial energy metabolism is linked to impaired function in human cardiomyocytes, whether exercise training and remote ischemic preconditioning can restore cardiomyocyte function and whether this is linked to improved mitochondrial and cell function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Injury
- What is being tested?
- Exercise training and remote ischemic preconditioning
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to Jul 2013
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing coronary heart surgery and heart transplantation
Who cannot join
- myocardial infarction closer than 4 weeks to project start, serious valve defects, diabetes, unstable angina, uncontrolled hypertension, kidney failure (creatinin > 140)
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian University of Science and Technology, Medical Faculty
Trondheim, Sør-Trondelag, 7489
About this study
Official title: Study of Gaining Further Understanding of the Underlying Mechanisms of Myocardial Function
The main focus of the project is to determine to what degree myocardial energy metabolism is linked to impaired function in human cardiomyocytes, whether exercise training and remote ischemic preconditioning can restore cardiomyocyte function and whether this is linked to improved mitochondrial and cell function.
- Conditions
- Myocardial Injury
- Being tested
- Exercise training, remote ischemic preconditioning
- Keywords
- Physical Activity, pathology, Physical Deconditioning
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
exercise training
remote ischemic preconditioningProcedure or surgery
remote ischemic preconditioning
| Study group | Role | What they receive |
|---|---|---|
| ExerciseTr | Experimental | Not described Receives: Behavioral: Exercise training |
| Remote ischemic preconditioning group | Experimental | Not described Receives: Procedure: remote ischemic preconditioning |
| Control patient group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial respiration
Oxygraph (Strathkelvin)
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 posted3 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Katrine Hordnes, MD, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308138
- Sponsor's protocol ID
- TRIMRIPC
- Acronym
- TRIMRIPC
- Status last verified
- Aug 2015
- First submitted
- 2 Feb 2011
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Slagsvold KH, Moreira JB, Rognmo O, Hoydal M, Bye A, Wisloff U, Wahba A. Remote ischemic preconditioning preserves mitochondrial function and activates pro-survival protein kinase Akt in the left ventricle during cardiac surgery: a randomized trial. Int J Cardiol. 2014 Dec 15;177(2):409-17. doi: 10.1016/j.ijcard.2014.09.206. Epub 2014 Oct 14.
PubMed 25456576Slagsvold KH, Rognmo O, Hoydal M, Wisloff U, Wahba A. Remote ischemic preconditioning preserves mitochondrial function and influences myocardial microRNA expression in atrial myocardium during coronary bypass surgery. Circ Res. 2014 Feb 28;114(5):851-9. doi: 10.1161/CIRCRESAHA.114.302751. Epub 2013 Dec 26.
PubMed 24371264
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Gaining Further Understanding of the Underlying Mechanisms of Myocardial Function
- ClinicalTrials.gov ID
- NCT01308138
- Acronym / sponsor ID
- TRIMRIPC / TRIMRIPC
- Conditions
- Myocardial Injury
- Keywords
- Physical Activity, pathology, Physical Deconditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Jan 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 3 Mar 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 main focus of the project is to determine to what degree myocardial energy metabolism is linked to impaired function in human cardiomyocytes, whether exercise training and remote ischemic preconditioning can restore cardiomyocyte function and whether this is linked to improved mitochondrial and cell function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ExerciseTr | Experimental | Behavioral: Exercise training |
| Remote ischemic preconditioning group | Experimental | Procedure: remote ischemic preconditioning |
| Control patient group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing coronary heart surgery and heart transplantation
Key exclusion criteria (1 listed)
- myocardial infarction closer than 4 weeks to project start, serious valve defects, diabetes, unstable angina, uncontrolled hypertension, kidney failure (creatinin > 140)
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 |
|---|---|---|
| Exercise trainingexercise training | Behavioural | ExerciseTr |
| remote ischemic preconditioningremote ischemic preconditioning | Procedure or surgery | Remote ischemic preconditioning group |
Primary outcome
Mitochondrial respiration
Time frame: 1 hour
Oxygraph (Strathkelvin)
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 Aug 2015.
- Results publication: PubMed 25456576Slagsvold KH, Moreira JB, Rognmo O, Hoydal M, Bye A, Wisloff U, Wahba A. Remote ischemic preconditioning preserves mitochondrial function and activates pro-survival protein kinase Akt in the left ventricle during cardiac surgery: a randomized trial. Int J Cardiol. 2014 Dec 15;177(2):409-17. doi: 10.1016/j.ijcard.2014.09.206. Epub 2014 Oct 14.
- Derived from this study: PubMed 24371264Slagsvold KH, Rognmo O, Hoydal M, Wisloff U, Wahba A. Remote ischemic preconditioning preserves mitochondrial function and influences myocardial microRNA expression in atrial myocardium during coronary bypass surgery. Circ Res. 2014 Feb 28;114(5):851-9. doi: 10.1161/CIRCRESAHA.114.302751. Epub 2013 Dec 26.
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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.
Katrine Hordnes, MD principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training and remote ischemic preconditioning in people with Myocardial Injury, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 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 20 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 Norway. 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?
Mitochondrial respiration (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 NCT01308138, which also lists 2 linked publications.
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 Aug 2015.