Does Caffeine Reduce Rosuvastatin-Induced Protection Against Ischemia-Reperfusion Injury?

Radboud University Medical Center24 enrolled

Overview

Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?

Rosuvastatin is a proven cholesterol lowering medicine, which hereby is assumed to achieve a reduction in cardiovascular events. Apart from it's cholesterol lowering action, rosuvastatin may also increase tolerance against ischemia-reperfusion injury. In dogs rosuvastatin increases the endogenous concentration of adenosine, by enhancing the activity of the enzyme ecto-5'-nucleotidase, which converts adenosine monophosphate into adenosine. We hypothesize that rosuvastatin increases tolerance against ischemia-reperfusion injury by induction of ecto-5'-nucleotidase and thereby increasing adenosine activity. This protective effect of rosuvastatin can be abrogated by using the adenosine receptor antagonist caffeine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Ischemia Reperfusion Injury

Interventions

RosuvastatinDRUG

7 day treatment rosuvastatin 20mg

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male * age between 18-50 yrs * signed informed consent Exclusion Criteria: * Cardiovascular disease * Hypertension (systole \> 140 mmHg, diastole \> 90 mmHg) * Hypercholesterolemia (fasting total cholesterol \> 6,0 mmol/l) * Drug abuse * Concomitant medication use * Inability to perform the ischemic isometric muscle contraction * Diabetes Mellitus (fasting glucose \> 7.0 mmol/L or random glucose \> 11.0 mmol/L) * Alanine-Amino-Transferase (ALAT) \>90U/L (more than twice the upper level of the normal range) * Creatinine Kinase (CK) \>340U/L (more than twice the upper level of the normal range) * Participation in any trial concerning medicinal products during the last 60 days prior to this study. * Participation in clinical trial involving

Locations (1)

UMCN st.Radboud

Nijmegen, Netherlands

Outcomes

Primary Outcomes

The targeting of Technetium 99 labeled Annexin A5 is recorded with a gamma camera as a endpoint measure of ischemia-reperfusion damage.

Time frame: 60 and 240 minutes after ischemic exercise

Secondary Outcomes

Workload (product of 50% of the maximum forearm force and duration of the ischemic exercise)

Time frame: during 10 minutes of ischemic exercise

The effect of one-week treatment of rosuvastatin 20mg once daily on lipid spectrum.

Time frame: before and after 7day treatment

The caffeine serum concentration after 24 hour abstinence .

Time frame: morning after 24 hours abstinence of caffeine

Data from ClinicalTrials.gov

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