ischemia-reperfusion injury MedDRA version: 9.1 Level: LLT Classification code 10023033 Term: Ischemia myocardial
Conditions
Interventions
Trade Name: lipitor
Product Name: atorvastatin
Pharmaceutical Form: Capsule*
INN or Proposed INN: atorvastatin
CAS Number: 134523-00-5
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
RUNMC
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Male - Age 18-50 years - Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History of any cardiovascular disease - Hypertension (in supine position: systole > 140 mmHg, diastole > 90 mmHg) - Diabetes mellitus (fasting glucose > 7.0 mmol/L or random glucose > 11.0 mmol/L) - Hyperlipidaemia (fasting total cholesterol > 5.0 mmol/l or random total cholesterol >6.5mmol/l) - Alanine-Amino-Transferase (ALAT) >90 U/L (more than twice the upper level of the normal range) - Creatinine Kinase (CK) >440 U/L (more than twice the upper level of the normal range) - Glomerular filtration rate <60ml/min/1.72m2 (assessed using MDRD calculation using gender, age and serum creatinine level) - Overt clinical signs of hypothyreoidy - Concomitant chronic use of medication - Administration of radioactivity for research purposes during the last 5 years - Participation to any drug-investigation during the previous 60 days as checked with VIP check according to CRCN standard procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting (acute and prolonged) after ischemic exercise in the non-dominant forearm. This to confirm results from our previous study (CMO 2006/274, ABR NL15624.091.06);Secondary Objective: workload during ischemic exercise, effect of 3-day treatment with atorvastatin 80mg daily on serum lipid levels;Primary end point(s): Percentage difference in radioactivity (counts/pixel) between experimental and control thenar muscle at 60 and 240 minutes after reperfusion. | — |
Countries
Netherlands
Outcome results
None listed