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

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

      • Nijmegen, Netherlands, 6500HB
        • Radboud University Nijmegen Medical Centre

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:
  • persatin
caffeine 4mg/kg iv
PLACEBO_COMPARATOR: 2
dipyridamol during 7 days and before ischemic exercise placebo
Dipyridamole 2x200mg 7day per os
Other Names:
  • persatin

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
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
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.

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

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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