IschemiaIPC in MRINCT00883467
The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia
A study testing preconditioning and no preconditioning in people with Ischemia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Ischemia reperfusion injury may be reduced by ischemic preconditioning. This projects aims to show the effects of short and long time ischemic preconditioning (both sequences 3 x 5 minutes) during and after an ischemic period of 20 minutes in healthy subjects by functional MRI. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ischemia
- What is being tested?
- preconditioning and no preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustria
- Study dates
- May 2008to Jun 2009
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged between 18 and 45 years
- Nonsmoker for more than 3 months
- Body mass index between 18 and 25 kg/m2
- Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Who cannot join
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
- Treatment in the previous 3 weeks with any drug including over-the-counter drugs
- Symptoms of a clinically relevant illness in the 2 weeks before the first study day
- Blood donation during the previous 3 weeks
- Any metallic, electric, electronic or magnetic device or object not removable
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, 1090
About this study
Ischemia reperfusion injury may be reduced by ischemic preconditioning. This projects aims to show the effects of short and long time ischemic preconditioning (both sequences 3 x 5 minutes) during and after an ischemic period of 20 minutes in healthy subjects by functional MRI. Ischemia is produces by cuff inflation to a suprasystolic pressure on one tight. Signal is acquired from calf muscles.
A cross-over design of 4 to 8 study periods is used, 4 different study days with 2 different MR measurement methods (BOLD imaging and high energy phosphates) are planned.
- Conditions
- Ischemia
- Being tested
- preconditioning, no preconditioning
- Keywords
- Ischemic Preconditioning, functional MRI, BOLD, Reperfusion
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preconditioningProcedure or surgery
3 times of five minutes ischemia, produced by cuff inflation to a suprasystolic pressure positioned on the thigh
no preconditioningProcedure or surgery
no preconditioning
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | baseline MR signal prior to, during and 30 minutes after an ischemic period of 20 minutes Receives: Procedure: no preconditioning |
| 2 | Other | baseline MR signal prior to, during and 30 minutes after an ischemic period of 20 minutes with additional 5 minutes of cuff stenosis directly after cuff release Receives: Procedure: no preconditioning |
| 3 | Other | short time preconditioning, other details according arm 2 Receives: Procedure: preconditioning |
| 4 | Other | long time preconditioning, other details according arm 2 Receives: Procedure: preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cellular high energy phosphate levels and venous pH concentration for 31P MRS
Measured: during and 30 min after ischemia
Main outcome variables: Change in cellular oxygen saturation for BOLD MRI
Measured: during and 30 minutes after ischemia
Serum markers of myocellular injury (myoglobin, creatine-kinase)
Measured: prior to, directly and 24 hours after ischemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startMay 2008
- Primary completionJun 2009 (estimated)
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 IschemiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Michael Wolzt, MD, Principal investigator, MUV, Department of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883467
- Sponsor's protocol ID
- IPC in MRI 040908
- Acronym
- IPC in MRI
- Status last verified
- Apr 2009
- First submitted
- 16 Apr 2009
- Last updated
- 17 Apr 2009
- Results posted
- No
Publications
Andreas M, Schmid AI, Keilani M, Doberer D, Bartko J, Crevenna R, Moser E, Wolzt M. Effect of ischemic preconditioning in skeletal muscle measured by functional magnetic resonance imaging and spectroscopy: a randomized crossover trial. J Cardiovasc Magn Reson. 2011 Jun 30;13(1):32. doi: 10.1186/1532-429X-13-32.
PubMed 21718491
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia
- ClinicalTrials.gov ID
- NCT00883467
- Acronym / sponsor ID
- IPC in MRI / IPC in MRI 040908
- Conditions
- Ischemia
- Keywords
- Ischemic Preconditioning, functional MRI, BOLD, Reperfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2009 (estimated)
- First posted
- 17 Apr 2009 (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.
Ischemia reperfusion injury may be reduced by ischemic preconditioning. This projects aims to show the effects of short and long time ischemic preconditioning (both sequences 3 x 5 minutes) during and after an ischemic period of 20 minutes in healthy subjects by functional MRI. Ischemia is produces by cuff inflation to a suprasystolic pressure on one tight. Signal is acquired from calf muscles.
A cross-over design of 4 to 8 study periods is used, 4 different study days with 2 different MR measurement methods (BOLD imaging and high energy phosphates) are planned.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: no preconditioningbaseline MR signal prior to, during and 30 minutes after an ischemic period of 20 minutes |
| 2 | Other | Procedure: no preconditioningbaseline MR signal prior to, during and 30 minutes after an ischemic period of 20 minutes with additional 5 minutes of cuff stenosis directly after cuff release |
| 3 | Other | Procedure: preconditioningshort time preconditioning, other details according arm 2 |
| 4 | Other | Procedure: preconditioninglong time preconditioning, other details according arm 2 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men aged between 18 and 45 years
- Nonsmoker for more than 3 months
- Body mass index between 18 and 25 kg/m2
- Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Key exclusion criteria (7 listed)
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
- Treatment in the previous 3 weeks with any drug including over-the-counter drugs
- Symptoms of a clinically relevant illness in the 2 weeks before the first study day
- Blood donation during the previous 3 weeks
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 |
|---|---|---|
| preconditioning3 times of five minutes ischemia, produced by cuff inflation to a suprasystolic pressure positioned on the thigh | Procedure or surgery | 3, 4 |
| no preconditioningno preconditioning | Procedure or surgery | 1, 2 |
Primary outcome
Change in cellular high energy phosphate levels and venous pH concentration for 31P MRS
Time frame: during and 30 min after ischemia
Main outcome variables: Change in cellular oxygen saturation for BOLD MRI
Time frame: during and 30 minutes after ischemia
Serum markers of myocellular injury (myoglobin, creatine-kinase)
Time frame: prior to, directly and 24 hours after ischemia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2009.
- Derived from this study: PubMed 21718491Andreas M, Schmid AI, Keilani M, Doberer D, Bartko J, Crevenna R, Moser E, Wolzt M. Effect of ischemic preconditioning in skeletal muscle measured by functional magnetic resonance imaging and spectroscopy: a randomized crossover trial. J Cardiovasc Magn Reson. 2011 Jun 30;13(1):32. doi: 10.1186/1532-429X-13-32.
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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.
Michael Wolzt, MD principal investigator
MUV, Department of Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preconditioning and no preconditioning in people with Ischemia, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 17 Apr 2009. 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 Austria. 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?
Results are not available in the source record.
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?
Change in cellular high energy phosphate levels and venous pH concentration for 31P MRS (time frame: during and 30 min after ischemia). The study lists 3 primary outcomes in all. 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 NCT00883467, 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 17 Apr 2009.