Modulation of Cerebral Blood Flow Using Iron Chelators

Early Phase 1CompletedNCT01365104

Brigham and Women's Hospital97 enrolled

Overview

The purpose of this study is determine if the iron chelator, desferrioxamine can increase blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a corresponding increase in blood flow to the brain.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Stroke Problem of Aging

Interventions

desferrioxamineDRUG

intravenous infusion at 10mg/kg/hr for a total of 6 hours at final infused doses of 60mg/kg.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy adults between the ages of 18-80 years. Exclusion Criteria: * subjects taking vasoactive medications, * hypertension, * pregnant women, smokers, * COPD, * asthma, * diabetes mellitus, * intracranial or carotid stenosis, * hepatic disease, * renal disease, * bone marrow suppression, * cardiac disease, * heart failure, * iron deficiency, * history of cancer, * history of head trauma, * subarachnoid hemorrhage, * central nervous system vasculitis, * multiple sclerosis, * migraines, * seizures, * sickle cell disease or trait, * cardiac arrhythmia, * unable to give informed consent, or * poor transcranial Doppler insonation windows.

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Define change from baseline cerebral blood flow after receiving DFO infusion.

Cerebral blood flow is measured with transcranial Doppler ultrasound at baseline and then study drug is initiated. Blood flow is measured again after 3 hours of infusion, 6 hours of infusion, then once more 3 hours after the infusion is complete.

Time frame: baseline, 3hr, 6hr, 9hr

Determine if DFO changes blood HIF-1 levels from baseline and whether this correlates with changes in cerebrovascular hemodynamics.

Blood samples are taken at each time point and will be correlated with ultrasound blood flow measures taken at baseline, 3hrs of infusion, 6hrs of infusion, and 3 hours after infusion is complete.

Time frame: baseline, 3hr, 6hr, 9hr

Data from ClinicalTrials.gov

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