The Effect of Caffeine on Ischemic Preconditioning

Caffeine Clinical Trial

Official title:

Caffeine Reduces Acute Ischemic Preconditioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184912
• Other study ID #: CAFIRI
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: November 28, 2006
• Start date: September 2003
• Est. completion date: January 2006

Study information

• Verified date: February 2006
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• healthy male volunteers

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Caffeine
• Ischemia
• Ischemia-Reperfusion Injury
• Ischemic Preconditioning
• Reperfusion Injury

Intervention

Drug:
• caffeine

• Technetium-TC99m-labeled Annexin A5

Procedure:
• ten minutes forearm ischemia

• ischemic forearm exercise

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre / Department of Pharmacology and Toxicology	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Riksen NP, Zhou Z, Oyen WJ, Jaspers R, Ramakers BP, Brouwer RM, Boerman OC, Steinmetz N, Smits P, Rongen GA. Caffeine prevents protection in two human models of ischemic preconditioning. J Am Coll Cardiol. 2006 Aug 15;48(4):700-7. Epub 2006 Jul 24. — View Citation

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. Epub 2004 Dec 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentual difference in Annexin A5 targetting between the experimental and control arm one and four hours after intravenous injection.