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The Effect of Caffeine on Ischemic Preconditioning

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00184912
First received: September 12, 2005
Last updated: November 28, 2006
Last verified: February 2006
History of Changes
  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-Blind
Official Title: Caffeine Reduces Acute Ischemic Preconditioning

Resource links provided by NLM:

MedlinePlus related topics: Caffeine
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male volunteers

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 12, 2005
Last Updated: November 28, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 21, 2013