Short term statin treatment and endothelial dysfunction due to ischemia and reperfusion injury

Conditions: ischemia and reperfusion injuryendothelial dysfunction
MedDRA version: 12.0Level: LLTClassification code 10063837Term: Reperfusion injury

Registration Number: EUCTR2009-014831-18-NL

Lead Sponsor: RUNMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 48

Inclusion Criteria

-Age 18-50
-Written 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

- Smoking
- 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)
- Hyperlipidemia (fasting total cholesterol >5.5 mmol/L or random cholesterol >6.5
mmol/L)
- Alanine amino transferase >90 U/L
- Creatine kinase >440 U/L
- Raised rabdomyolysis risk
o GFR <60 ml/min
o Overt clinical signs of hypothyroidism
o Myopathy in family history
o Alcohol abuse
- Concomitant chronic use of medication
- Participation to any drug-investigation during the previous 60 days as checked with
VIP check

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the protective effect of pretreatment (both 3 day and 7 day) with rosuvastatin and atorvastatin on flow mediated dilation after 15 minutes ischemia and 15 minutes reperfusion.;Secondary Objective: ecto-5’-nucleotidase activity after rosuvastatin and atorvastatin treatment (3 day and 7 day);Primary end point(s): Difference in flow mediated dilation before and after 15 minutes ischemia.

Secondary Outcome Measures