MedPath

Modulation of Cerebral Blood Flow Using Iron Chelators

Early Phase 1
Completed
Conditions
Stroke
Problem of Aging
Interventions
Registration Number
NCT01365104
Lead Sponsor
Brigham and Women's Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
97
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Healthy youngdesferrioxamineEach subject comes for 2 visits. There is a randomized, double-blind, crossover design so each subject will receive active drug during one visit and placebo during the other.
healthy olddesferrioxamineEach subject comes for 2 visits. There is a randomized, double-blind, crossover design so each subject will receive active drug during one visit and placebo during the other.
Primary Outcome Measures
NameTimeMethod
Define change from baseline cerebral blood flow after receiving DFO infusion.baseline, 3hr, 6hr, 9hr

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.

Determine if DFO changes blood HIF-1 levels from baseline and whether this correlates with changes in cerebrovascular hemodynamics.baseline, 3hr, 6hr, 9hr

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Brigham and Women's Hospital

🇺🇸

Boston, Massachusetts, United States

© Copyright 2025. All Rights Reserved by MedPath