atherosclerosis MedDRA version: 9.1 Level: LLT Classification code 10003601 Term: Atherosclerosis
Conditions
Interventions
Product Name: adenosine triphosphate
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intraarterial use
Trade Name: adenocor
Prod
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 > 5.5 mmol/l or random cholesterol > 6.5mmol/L) - Drug abuse - 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 on intra-arterial ATP infusion on Annexin A5 targeting.;Secondary Objective: To study influence of adenosine infusion and ischemic preconditioning on ATP induced Annexin A5 targeting.;Primary end point(s): Percentage difference in radioactivity (counts/pixel) between experimental and control thenar muscle at 60 and 240 minutes after intervention. | — |
Countries
Netherlands
Outcome results
None listed