Does atorvastatin have an acute and prolonged inhibitory effect on ischemia-reperfusion injury in humans in-vivo?

Phase 4

Completed

• Conditions: ischemia reperfusion-injury; myocardial infarction; 10011082

• Registration Number: NL-OMON32029
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

- Male
- Age 18-50 years
- Informed consent

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Annexin A 5 targeting in the non-dominant thenar muscle after ischemic<br /><br>exercise, as a indicator for ischemia reperfusion injury.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>workload during ischemic exercise, effect of 3-day treatment with atorvastatin<br /><br>80mg daily on serum lipid levels</p><br>