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Does cafeine reduce rosuvastatin-induced protection against ischemia-reperfusion injury?

Does cafeine reduce rosuvastatin-induced protection against ischemia-reperfusion injury? - rosucof

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30751
Enrollment
24
Registered
2007-02-09
Start date
2007-03-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart infarction Ischemia-reperfusion injury

Interventions

24 healthy male volunteers receive a one week treatment with 20 mg rosuvastatin daily. On day 7, after at least 24 hours of caffeine abstinence all volunteers will be randomised to receive either pl

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male age between 18-50 yrs signed informed consent

Exclusion criteria

Exclusion criteria: -Cardiovascular disease -Hypertension (systole > 140 mmHg, diastole > 90 mmHg) -Hypercholesterolemia (fasting total cholesterol > 6,0 mmol/l) -Drug abuse -Concomittant 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 administration of radioactivity more than 5mSv, during the 5 years prior to this study.

Design outcomes

Primary

MeasureTime frame
Annexin A5 targeting (% difference in radioactivity (counts per pixel) between experimental and control thenar muscle after ischemic exercise, as a indicator for ischemia reperfusion injury.

Secondary

MeasureTime frame
-Workload (product of 50% of the maximum forearm force and duration of the ischemic exercise) -The effect of one-week treatment of rosuvastatine 20mg once daily on lipid spectrum. -The caffeine serum concentration after 24 hour abstinence, and after infusion of cafeine (4mg/kg) or placebo.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)