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Does atorvastatin reduce ischemia-reperfusion injury in humans in-vivo?

Does atorvastatin reduce ischemia-reperfusion injury in humans in-vivo? - Ator01

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30203
Enrollment
12
Registered
2006-12-29
Start date
2007-01-01
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

ischemia reperfusion injury myocardial infarction

Interventions

in a cross-over design all volunteers receive 3 day treatment with atorvastatin 80mg daily or placebo. Between the active treatment period and the placebo period, a wash-out period of at least 4 wee

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Male -Age 18-50 years -Informed consent -Physical able to perform ischemic exercise

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 (random total cholesterol > 6 mmol/l) -Alanine-Amino-Transferase (ALAT) >90 U/L (more than twice the upper level of the normal range) -Creatinine Kinase (CK) >340 U/L (more than twice the upper level of the normal range) -Drug abuse -Concomitant chronic use of medication -Administration of radioactivity in research setting 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

MeasureTime frame
Annexin A 5 targeting in the non dominant thenar muscle after ischemic exercise, as a indicator for ischemia reperfusion injury

Secondary

MeasureTime frame
Fasting lipid profile before and after three day therapy with atorvastatin 80mg. Workload performed during ischemic exercise.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)