This proposal is for the Clinical Trials Statistical and Data Management Center (CTSDMC) in the Department of Biostatistics, College of Public Health at the University of Iowa for the Carotid Occlusion Surgery Study (COSS) and covers the activities of the CTSDMC. Dr. William Powers is submitting a separate proposal for the Clinical Coordinating Center (CCC) for this trial. The goal of this study is to test the hypothesis that extra cranial-intra cranial (EC/IC) arterial bypass by surgical anastomosis of the superficial temporal artery to the middle cerebral artery (STA-MCA) when added to best medical therapy can reduce by 40%, despite perioperative stroke and death, subsequent ipsilateral ischemic stroke (fatal and non-fatal) at two years in patients with symptomatic carotid artery occlusion and increased oxygen extraction fraction measured by positron emission tomography (PET). This is a randomized, non-blinded, controlled trial in 372 participants randomized equally to surgical and non-surgical treatment. Participants who fulfill clinical entry criteria and who have carotid occlusion in at least one carotid artery by vascular imaging will be eligible for enrollment to undergo PET. If PET criteria is met then arteriographic criteria must be met for the participant to be randomized. All randomized participants will receive the best available medical treatment with anti-thrombotic agents and risk factor intervention to prevent subsequent stroke. Participants are followed for 24 months at 3 month intervals. The CTSDMC brings over 30 years experience in the design and implementation of clinical and epidemiology studies and over 14 years experience serving as the data coordinating center for multi-center clinical trials. These studies include studies in neurology, nephrology, and diabetes. The CTSDMC staff has successfully developed and operated web based data entry systems and databases for multi-center trials and have a excellent record in successfully coordinating clinical trials.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01NS041895-09
Application #
8050617
Study Section
Special Emphasis Panel (ZNS1-SRB-W (26))
Program Officer
Janis, Scott
Project Start
2001-09-30
Project End
2012-11-30
Budget Start
2010-12-01
Budget End
2012-11-30
Support Year
9
Fiscal Year
2011
Total Cost
$477,868
Indirect Cost
Name
University of Iowa
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
062761671
City
Iowa City
State
IA
Country
United States
Zip Code
52242
Reynolds, Matthew R; Kamath, Ashwin A; Grubb, Robert L et al. (2014) The safety of aeroplane travel in patients with symptomatic carotid occlusion. J Neurol Neurosurg Psychiatry 85:435-7
Powers, William J; Clarke, William R; Grubb Jr, Robert L et al. (2014) Lower stroke risk with lower blood pressure in hemodynamic cerebral ischemia. Neurology 82:1027-32
Marshall, Randolph S; Festa, Joanne R; Cheung, Ying-Kuen et al. (2014) Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON) trial: main results. Neurology 82:744-51
Grubb Jr, Robert L; Powers, William J; Clarke, William R et al. (2013) Surgical results of the Carotid Occlusion Surgery Study. J Neurosurg 118:25-33
Marshall, R S; Festa, J R; Cheung, Y K et al. (2012) Cerebral hemodynamics and cognitive impairment: baseline data from the RECON trial. Neurology 78:250-5
Powers, William J (2012) Letter by Powers Regarding Article, ""Failure of cerebral hemodynamic selection in general or of specific positron emission tomography methodology? Carotid occlusion surgery study (COSS)"". Stroke 43:e43
Mikami, Katsunaka; Jorge, Ricardo E; Adams Jr, Harold P et al. (2011) Effect of antidepressants on the course of disability following stroke. Am J Geriatr Psychiatry 19:1007-15
Powers, William J; Clarke, William R; Grubb Jr, Robert L et al. (2011) Extracranial-intracranial bypass surgery for stroke prevention in hemodynamic cerebral ischemia: the Carotid Occlusion Surgery Study randomized trial. JAMA 306:1983-92
Ying Zhang; Clarke, William R (2010) A flexible futility monitoring method with time-varying conditional power boundary. Clin Trials 7:209-18