Myocardial ischemia-reperfusion injury. MedDRA version: 9.1 Level: LLT Classification code 10059512 Term: Apoptosis MedDRA version: 9.1 Level: LLT Classification code 10028601 Term: Myocardial ischemia MedDRA version: 9.1 Level: LLT Classification code 10051624 Term: Myocardial reperfusion injury
Conditions
Interventions
Trade Name: Eprex
Pharmaceutical Form: Solution for injection
INN or Proposed INN: EPOETIN ALFA
CAS Number: 113427240
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 4000
Sponsors
University Medical Center Groningen, dept. of Cardiology
University Medical Center Nijmegen, dept. of Pharmacology-Toxicology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Healthy volunteers between 18 and 40 years of age. • Male. • Volunteers are not allowed smoking 24 hours before the start of the experiment. 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: • Female. • Hypertension (SBP >140 mmHg, DBP >90 mmHg). • Diabetes Mellitus (DM) (fasting glc >6.9 mmol/l, glc >11.0 mmol/l). • Hypercholesterolemia. • Renal dysfunction (eGFR < 60 ml/min, calculated using MDRD formula). • Any known hypersensitivity/allergic reaction to one of the constituents of Epoetin Alfa. • A history of use of any form of EPO. • Any current medication use. • Cardiovascular disease in medical history. • Smoking less than 24 hours prior to Epoetin alpha infusion. • Participation in research in the last 5 years in which any form of radioactivity was used. • No participation in any research trial in the last 30 days or 5 times the half-life of the used substance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does infusion of a single dose of Epoetin Alfa, a short-acting EPO, prevents targeting of annexin A5 in man after acute ischemia?;Secondary Objective: ;Primary end point(s): The percentage of difference between radioactivity (quantified as counts per pixel) of the predefined area of interest of the experimental and control thenar muscle at one and four hours after reperfusion. | — |
Countries
Netherlands
Outcome results
None listed