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Bevacizumab and endothelium dependent vasodilation

Bevacizumab and endothelium dependent vasodilation - BVZach

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32503
Enrollment
24
Registered
2009-12-28
Start date
2010-06-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

high blood pressure Hypertension

Interventions

The brachial artery will be cannulated (20 gauge catheter) for infusion of bevacizumab 144 microgram/dl forearm volume ( 15 minutes).

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-50 years old 2. Male 3. Results of serum glucose, lipids and creatinine should be within the laboratory's reference ranges. 4. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

Exclusion criteria

Exclusion criteria: 1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients. 2. History of or current abuse of drugs, alcohol or solvents. 3. History of malignant disease. 4. First degree relatives with a history of cancer before the age of 50 5. First degree relatives with a history of premature cardiovascular disease before the age of 50 6. Current use of medication. 7. Hypertension ( systole >140mmHG, diastole >90mmHg) 8. Diabetes mellitus 9. Smoking 10. Any clinically relevant abnormality on ECG. 11. A history of thrombosis or first degree family members with a history of recurrent thrombosis 12. Inability to understand the nature and extent of the trial and the procedures required. 14. Previous participation in a study with bevacizumab.

Design outcomes

Primary

MeasureTime frame
The forearm vasomotor response to increasing doses of intra-arterially administered acetylcholine (two doses each) before and during administration of bevacizumab, expressed as percentage change in forearm blood flow ratio (flow infused arm/flow control arm) from baseline.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)