Ischemia Reperfusion: Prostaglandins and Antioxidants
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| ClinicalTrials.gov Identifier: NCT01666587 |
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Recruitment Status
:
Completed
First Posted
: August 16, 2012
Last Update Posted
: May 12, 2017
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Sponsor:
University of Essex
Information provided by (Responsible Party):
Mark Rakobowchuk, University of Essex
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Brief 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. 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?
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ischemic Reperfusion Injury | Dietary Supplement: Antioxidant Drug: Prostaglandin inhibitor (Ibuprophen) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 12 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Basic Science |
| Official Title: | The Role of Prostaglandin and Anti-oxidant Availability on Recovery From Forearm Ischemia-reperfusion Injury in Humans |
| Study Start Date : | August 2012 |
| Actual Primary Completion Date : | April 2013 |
| Actual Study Completion Date : | August 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Antioxidants
Drug Information available for:
Ibuprofen
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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No Intervention: control
Control trial to determine the impact of the ischemic injury on vascular function without intervention
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Experimental: Antioxidant load
Trial to determine the impact of an antioxidant load before the ischemic injury on vascular function recovery
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Dietary Supplement: Antioxidant |
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Experimental: Prostaglandin inhibition
Trial to determine the impact of a non-selective prostaglandin inhibitor before the ischemic injury on vascular function recovery
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Drug: Prostaglandin inhibitor (Ibuprophen)
Other Name: ibuprofen
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Experimental: Combined
Trial to determine the impact of an antioxidant load and prostaglandin inhibitor before the ischemic injury on vascular function recovery
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Dietary Supplement: Antioxidant
Drug: Prostaglandin inhibitor (Ibuprophen)
Other Name: ibuprofen
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Primary Outcome Measures
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- 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.
Secondary Outcome Measures
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- Change in low flow mediated constriction [ Time Frame: Change from baseline at 15 minutes after ischemia-reperfusion injury ]low flow mediated constriction is a measure of vascular function and is measured to establish the impact of a vascular injury
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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy males
- Healthy females
Exclusion Criteria:
- Smokers
- Cardiovascular disease
- Peripheral vascular disease
- Neurological deficits
- Diabetes Type I or II
- Pregnant women
- Adverse reactions to Ibuprofen
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666587
Locations
| United Kingdom | |
| University of Essex | |
| Colchester, Essex, United Kingdom, CO4 3SQ | |
Sponsors and Collaborators
University of Essex
Investigators
| Principal Investigator: | Mark Rakobowchuk, PhD | Thompson Rivers University |
| Responsible Party: | Mark Rakobowchuk, Principle Investigator, University of Essex |
| ClinicalTrials.gov Identifier: | NCT01666587 History of Changes |
| Other Study ID Numbers: |
IRAPC DBD0300 ( Other Identifier: Biological Sciences ) |
| First Posted: | August 16, 2012 Key Record Dates |
| Last Update Posted: | May 12, 2017 |
| Last Verified: | May 2017 |
Additional relevant MeSH terms:
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Ischemia Reperfusion Injury Pathologic Processes Vascular Diseases Cardiovascular Diseases Postoperative Complications Antioxidants |
Prostaglandin Antagonists Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |