Clinical Studies
Breast Care
Cardiology
Colon Cancer
Dermatology
Diabetes
Gastrointestinal
HIV/AIDS
Mental Health
Neurology
NeuroOphthalmology
Obesity/Weight Management
Women's Health
Other
Special Features
Advances/Research
| Principal Investigator: | Randolph S. Marshall, MD | |
| Time frame of study: | Ongoing | |
| Time frame of participation: | Two Years | |
| Number of participants needed: | 372 | |
| Location of Study: | Neurological Institute Columbia University Medical Center 710 W. 168th Street New York, NY 10032 |
|
| Contact Name, Number & Email: | General Info at (212) 305-8389 |
Summary:
This is a multi-center NIH-sponsored randomized clinical trial
to test the hypothesis that intracranial-extracranial (EC-IC) bypass surgery
can reduce by 40% the chance of stroke at two years in patients with recently
symptomatic internal carotid artery occlusion and ipsilateral increased
oxygen extraction fraction as measured by PET.
In the trial, patients first undergo positron emission tomography (PET)
to determine whether their cerebral blood flow is significantly impaired.
If the blood flow is shown to be low by PET, patients are randomized (like
a flip of a coin) to receive either EC-IC bypass or best medical therapy
alone. Patients in both treatment groups are followed every 3 months for
examinations, blood work, ultrasound, and maximization of their medical
care.
Criteria for
Participation:
Subjects may be aged 18-85, and must have an
occlusion of 1 carotid artery as documented by Doppler, magnetic resonance
angiography (MRA), computed tomographic angiography (CTA) or conventional
angiography, and have had symptoms (TIA or stroke) within 120 days of
enrollment in the study. Women participants must not be pregnant.
Duration:
The study duration is 2 years for
each patient.
Benefits/Compensation:
The costs of study visits and all
tests related to the study are provided at no charge. There is no payment
for participation in this study.