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The Effect of Caffeine on Ischemic Preconditioning

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00184912
First Posted: September 16, 2005
Last Update Posted: November 29, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University
  Purpose

Ischaemic preconditioning (IP) describes the phenomenon that brief periods of ischaemia render the (myocardial) muscle more resistant to a subsequent more prolonged period of ischaemia and reperfusion. Animal studies have provided evidence that adenosine receptor stimulation is an important mediator of IP. As caffeine is an effective adenosine receptor antagonist already at concentrations reached after regular coffee consumption, we aimed to assess whether caffeine impairs IP in humans in vivo. We used a novel and well-validated model to study IP in humans: 99m-Tc-annexin A5 scintigraphy in forearm skeletal muscle.

24 healthy volunteers were randomly assigned to either caffeine (4 mg/kg/iv in 10 minutes) or saline before a protocol for IP.


Condition Intervention
Caffeine Ischemic Preconditioning Ischemia-Reperfusion Injury Drug: caffeine Drug: Technetium-TC99m-labeled Annexin A5 Procedure: ten minutes forearm ischemia Procedure: ischemic forearm exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Caffeine Reduces Acute Ischemic Preconditioning

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Percentual difference in Annexin A5 targetting between the experimental and control arm one and four hours after intravenous injection.

Estimated Enrollment: 24
Study Start Date: September 2003
Estimated Study Completion Date: January 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male volunteers

Exclusion Criteria:

  Contacts and Locations
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): NCT00184912


Locations
Netherlands
Radboud University Nijmegen Medical Centre / Department of Pharmacology and Toxicology
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Gerard Rongen, MD, Phd Radboud University Nijmegen Medical Centre / Department of pharmacology and Toxicology
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00184912     History of Changes
Other Study ID Numbers: CAFIRI
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: November 29, 2006
Last Verified: February 2006

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Caffeine
Annexin A5
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents