- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00430170
Does Caffeine Reduce Dipyridamole-Induced Protection Against Ischemia-Reperfusion Injury?
July 28, 2008 updated by: Radboud University Medical Center
The purpose of this project is to explore the interaction between caffeine and dipyridamole on ischemia-reperfusion injury in the forearm.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Dipyridamole has been proven to reduce targeting of Annexin A5 in responses to ischemic exercise, indicating protection against ischemia-reperfusion injury in humans (pharmacological preconditioning).
Dipyridamole increases the endogenous adenosine level by inhibition of the nucleoside transporter (ENT-1).
Activation of the adenosine receptor protects against ischemia-reperfusion injury.
We hypothesize that endogenous adenosine mediates the protective effect of dipyridamole against ischemia-reperfusion injury.
Therefore the adenosine receptor antagonist caffeine will reduce the benefit of dipyridamole on forearm ischemia-reperfusion injury.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nijmegen, Netherlands, 6500HB
- Radboud University Nijmegen Medical Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- Age between 18-50yr.
Exclusion Criteria:
- cardiovascular disease
- hypertension (systole > 140 mmHg, diastole > 90 mmHg)
- hypercholesterolemia (random total cholesterol > 6.5 mmol/l)
- diabetes mellitus (fasting glucose > 7.0 mmol/L or random glucose > 11.0 mmol/L)
- asthma (recurrent episodes of dyspnea and wheezing, or usage of prescribed inhalation medication: i.e. corticosteroids or B2-agonists)
- participation in any clinical trial during the last 60 days prior to this study.
- administration of two doses of Annexin A5 (0,1mg; 450MBq) during the last 5 years prior to this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
dipyridamol during 7 days and before ischemic exercise caffeine 4mg/kg
|
Dipyridamole 2x200mg 7day per os
Other Names:
caffeine 4mg/kg iv
|
PLACEBO_COMPARATOR: 2
dipyridamol during 7 days and before ischemic exercise placebo
|
Dipyridamole 2x200mg 7day per os
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage difference in Annexin A5 targetting between experimental and control thenar muscle at 60 and 240 minutes after reperfusion
Time Frame: 60 and 240 minutes after ischemic exercise
|
60 and 240 minutes after ischemic exercise
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma dipyridamole concentration
Time Frame: at the morning of day 7 of treatment with dipyridamole/placebo
|
at the morning of day 7 of treatment with dipyridamole/placebo
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ENT transport activity (before and after treatment with dipyridamole 200mg, twice daily, for seven days)
Time Frame: before start of treatment (dipyridamol/placebo) and in the morning of day 7 of treatment (placebo/dipyridamol)
|
before start of treatment (dipyridamol/placebo) and in the morning of day 7 of treatment (placebo/dipyridamol)
|
Workload (duration of exercise and developed force)
Time Frame: during 10 minutes of ischemic exercise
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during 10 minutes of ischemic exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gerard Rongen, MD PhD, Radboud University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Riksen NP, Oyen WJ, Ramakers BP, Van den Broek PH, Engbersen R, Boerman OC, Smits P, Rongen GA. Oral therapy with dipyridamole limits ischemia-reperfusion injury in humans. Clin Pharmacol Ther. 2005 Jul;78(1):52-9. doi: 10.1016/j.clpt.2005.03.003.
- Rongen GA, Oyen WJ, Ramakers BP, Riksen NP, Boerman OC, Steinmetz N, Smits P. Annexin A5 scintigraphy of forearm as a novel in vivo model of skeletal muscle preconditioning in humans. Circulation. 2005 Jan 18;111(2):173-8. doi: 10.1161/01.CIR.0000151612.02223.F2. Epub 2004 Dec 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (ACTUAL)
March 1, 2007
Study Completion (ACTUAL)
April 1, 2007
Study Registration Dates
First Submitted
January 31, 2007
First Submitted That Met QC Criteria
January 31, 2007
First Posted (ESTIMATE)
February 1, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
July 29, 2008
Last Update Submitted That Met QC Criteria
July 28, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Vascular Diseases
- Postoperative Complications
- Cardiovascular Diseases
- Ischemia
- Wounds and Injuries
- Reperfusion Injury
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Enzyme Inhibitors
- Platelet Aggregation Inhibitors
- Purinergic Antagonists
- Purinergic Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Central Nervous System Stimulants
- Dipyridamole
- Caffeine
Other Study ID Numbers
- dipy001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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