CaffeineNCT00184912
The Effect of Caffeine on Ischemic Preconditioning
A study testing caffeine, Technetium-TC99m-labeled Annexin A5 and ten minutes forearm ischemia in people with Caffeine and Ischemic Preconditioning, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Caffeine, Ischemic Preconditioning, Ischemia-Reperfusion Injury
- What is being tested?
- caffeine, Technetium-TC99m-labeled Annexin A5 and ten minutes forearm ischemia
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2003to Jan 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male volunteers
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre / Department of Pharmacology and Toxicology
Nijmegen, Gelderland, 6500 HB
About this study
Official title: Caffeine Reduces Acute Ischemic Preconditioning
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.
- Being tested
- caffeine, Technetium-TC99m-labeled Annexin A5, ten minutes forearm ischemia, ischemic forearm exercise
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeineDrug
Technetium-TC99m-labeled Annexin A5Drug
ten minutes forearm ischemiaProcedure or surgery
ischemic forearm exerciseProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentual difference in Annexin A5 targetting between the experimental and control arm one and four hours after intravenous injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2003
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CaffeineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Gerard Rongen, MD, Phd, Principal investigator, Radboud University Nijmegen Medical Centre / Department of pharmacology and Toxicology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184912
- Sponsor's protocol ID
- CAFIRI
- Status last verified
- Feb 2006
- First submitted
- 12 Sep 2005
- Last updated
- 29 Nov 2006
- Results posted
- No
Publications
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.
PubMed 15623546Riksen 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. doi: 10.1016/j.jacc.2006.04.083. Epub 2006 Jul 24.
PubMed 16904537
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caffeine Reduces Acute Ischemic Preconditioning
- ClinicalTrials.gov ID
- NCT00184912
- Acronym / sponsor ID
- CAFIRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Sep 2003
- Study completion
- Jan 2006
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy male volunteers
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caffeine | Drug | – |
| Technetium-TC99m-labeled Annexin A5 | Drug | – |
| ten minutes forearm ischemia | Procedure or surgery | – |
| ischemic forearm exercise | Procedure or surgery | – |
Primary outcome
Percentual difference in Annexin A5 targetting between the experimental and control arm one and four hours after intravenous injection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2006.
- Background: PubMed 15623546Rongen 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.
- Results publication: PubMed 16904537Riksen 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. doi: 10.1016/j.jacc.2006.04.083. Epub 2006 Jul 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Rongen, MD, Phd principal investigator
Radboud University Nijmegen Medical Centre / Department of pharmacology and Toxicology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caffeine, Technetium-TC99m-labeled Annexin A5 and ten minutes forearm ischemia in people with Caffeine and Ischemic Preconditioning, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentual difference in Annexin A5 targetting between the experimental and control arm one and four hours after intravenous injection.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00184912, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2006.