Ischemic Reperfusion InjuryNCT01666587
Ischemia Reperfusion: Prostaglandins and Antioxidants
A study testing Antioxidant and Prostaglandin inhibitor (Ibuprophen) in people with Ischemic Reperfusion Injury, run by University of Essex at 1 site in United Kingdom.
Trial summary
The purposes of this study are two-fold. The first purpose is to determine the effect of taking vitamins on the recovery of an artery (blood vessel) following an induced temporary injury. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Reperfusion Injury
- What is being tested?
- Antioxidant and Prostaglandin inhibitor (Ibuprophen)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to Aug 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Healthy females
Who cannot join
- Smokers
- Cardiovascular disease
- Peripheral vascular disease
- Neurological deficits
- Diabetes Type I or II
- Pregnant women
- Adverse reactions to Ibuprofen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Prostaglandin and Anti-oxidant Availability on Recovery From Forearm Ischemia-reperfusion Injury in Humans
The purposes of this study are two-fold. The first purpose is to determine the effect of taking vitamins on the recovery of an artery (blood vessel) following an induced temporary injury. The second purpose is to determine whether a specific vasodilator is less abundant after the injury and whether this contributes to increased constriction or after the injury. Finally, does vitamin consumption have an effect on the recovery from the injury if one of the substances in the blood that causes vessels to enlarge (dilate) is stopped?
- Conditions
- Ischemic Reperfusion Injury
- Being tested
- Antioxidant, Prostaglandin inhibitor (Ibuprophen)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntioxidantDietary supplement
Prostaglandin inhibitor (Ibuprophen)Drug
Also called ibuprofen
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Control trial to determine the impact of the ischemic injury on vascular function without intervention |
| Antioxidant load | Experimental | Trial to determine the impact of an antioxidant load before the ischemic injury on vascular function recovery Receives: Dietary Supplement: Antioxidant |
| Prostaglandin inhibition | Experimental | Trial to determine the impact of a non-selective prostaglandin inhibitor before the ischemic injury on vascular function recovery Receives: Drug: Prostaglandin inhibitor (Ibuprophen) |
| Combined | Experimental | Trial to determine the impact of an antioxidant load and prostaglandin inhibitor before the ischemic injury on vascular function recovery Receives: Dietary Supplement: Antioxidant; Drug: Prostaglandin inhibitor (Ibuprophen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in flow mediated dilation
Flow mediated dilation is a measure of vascular function and is measured as the outcome before and after an injury to the inner lining of the artery.
Measured: Change from baseline at 15 minutes after ischemia-reperfusion injury
Secondary outcomes (1)
Change in low flow mediated constriction
low flow mediated constriction is a measure of vascular function and is measured to establish the impact of a vascular injury
Measured: Change from baseline at 15 minutes after ischemia-reperfusion injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Reperfusion InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Essex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Rakobowchuk, University of Essex
- Investigators
- Mark Rakobowchuk, PhD, Principal investigator, Thompson Rivers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666587
- Sponsor's protocol ID
- IRAPC
- Other IDs
- DBD0300
- Status last verified
- May 2017
- First submitted
- 9 Aug 2012
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Prostaglandin and Anti-oxidant Availability on Recovery From Forearm Ischemia-reperfusion Injury in Humans
- ClinicalTrials.gov ID
- NCT01666587
- Acronym / sponsor ID
- IRAPC
- Conditions
- Ischemic Reperfusion Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of EssexUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Aug 2012 (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 purposes of this study are two-fold. The first purpose is to determine the effect of taking vitamins on the recovery of an artery (blood vessel) following an induced temporary injury. The second purpose is to determine whether a specific vasodilator is less abundant after the injury and whether this contributes to increased constriction or after the injury. Finally, does vitamin consumption have an effect on the recovery from the injury if one of the substances in the blood that causes vessels to enlarge (dilate) is stopped?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Control trial to determine the impact of the ischemic injury on vascular function without intervention |
| Antioxidant load | Experimental | Dietary Supplement: AntioxidantTrial to determine the impact of an antioxidant load before the ischemic injury on vascular function recovery |
| Prostaglandin inhibition | Experimental | Drug: Prostaglandin inhibitor (Ibuprophen)Trial to determine the impact of a non-selective prostaglandin inhibitor before the ischemic injury on vascular function recovery |
| Combined | Experimental | Dietary Supplement: Antioxidant, Drug: Prostaglandin inhibitor (Ibuprophen)Trial to determine the impact of an antioxidant load and prostaglandin inhibitor before the ischemic injury on vascular function recovery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males
- Healthy females
Key exclusion criteria (7 listed)
- Smokers
- Cardiovascular disease
- Peripheral vascular disease
- Neurological deficits
- Diabetes Type I or II
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 |
|---|---|---|
| Antioxidant | Dietary supplement | Antioxidant load, Combined |
| Prostaglandin inhibitor (Ibuprophen)Also: ibuprofen | Drug | Combined, Prostaglandin inhibition |
Primary outcome
Change in flow mediated dilation
Time frame: Change from baseline at 15 minutes after ischemia-reperfusion injury
Flow mediated dilation is a measure of vascular function and is measured as the outcome before and after an injury to the inner lining of the artery.
1 secondary outcome
Change in low flow mediated constriction
Time frame: Change from baseline at 15 minutes after ischemia-reperfusion injury
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 12 May 2017.
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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.
Mark Rakobowchuk, PhD principal investigator
Thompson Rivers 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 Antioxidant and Prostaglandin inhibitor (Ibuprophen) in people with Ischemic Reperfusion Injury, run by University of Essex at 1 site in United Kingdom.
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 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: finished, as of the sponsor's last update on 12 May 2017. 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 Kingdom. 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?
Change in flow mediated dilation (time frame: Change from baseline at 15 minutes after ischemia-reperfusion injury). 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 12 May 2017.