This proposal is for a continuation of a prospective, multicenter randomized clinical trial of medical/surgical therapy to prevent TIA and stroke in asymptomatic patients with stenosis of the common carotid bulb and/or internal carotid sinus -- the site of more than 90% of hemodynamically significant carotid artery atherosclerosis. The major aim of the study is to determine whether the addition of carotid endarterectomy to aspirin (325 mg) + best medical management will reduce the incidence of TIA and cerebral infarction in asymptomatic patients with hemodynamically significant carotid stenosis. Secondary objectives are to determine: (1) the surgical success in lesion removal and incidence of recurrent carotid stenosis following carotid endarterectomy, (2) the rate of progression (or regression) of carotid atherosclerosis in the medically treated group and in the control carotid arterial system, and (3) the incidence of coronary artery events (angina pectoris, non-fatal and fatal myocardial infarction) during follow-up. Quality assurance is a major component in study design. The results of the North American Symptomatic Carotid Endarterectomy Trial have demonstrated that carotid endarterectomy is the treatment of choice for symptomatic carotid artery stenosis exceeding 70%. It is estimated that the symptomatic subset represents only 10% of the prevalence of carotid stenosis. Therefore, it is all the more urgent to determine whether similar results apply to asymptomatic patients.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project (R01)
Project #
5R01NS022611-10
Application #
2264564
Study Section
Special Emphasis Panel (SRC (05))
Project Start
1985-09-09
Project End
1997-02-28
Budget Start
1994-03-01
Budget End
1995-02-28
Support Year
10
Fiscal Year
1994
Total Cost
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Neurology
Type
Schools of Medicine
DUNS #
041418799
City
Winston-Salem
State
NC
Country
United States
Zip Code
27106
Baker, W H; Howard, V J; Howard, G et al. (2000) Effect of contralateral occlusion on long-term efficacy of endarterectomy in the asymptomatic carotid atherosclerosis study (ACAS). ACAS Investigators. Stroke 31:2330-4
Pettigrew, L C; Thomas, N; Howard, V J et al. (2000) Low mini-mental status predicts mortality in asymptomatic carotid arterial stenosis. Asymptomatic Carotid Atherosclerosis Study investigators. Neurology 55:30-4
Moore, W S; Kempczinski, R F; Nelson, J J et al. (1998) Recurrent carotid stenosis : results of the asymptomatic carotid atherosclerosis study. Stroke 29:2018-25
Karanjia, P N; Nelson, J J; Lefkowitz, D S et al. (1997) Validation of the ACAS TIA/stroke algorithm. Neurology 48:346-51
Castaldo, J E; Nelson, J J; Reed 3rd, J F et al. (1997) The delay in reporting symptoms of carotid artery stenosis in an at-risk population. The Asymptomatic Carotid Atherosclerosis Study experience: a statement of concern regarding watchful waiting. Arch Neurol 54:1267-71
Schwartz, S W; Chambless, L E; Baker, W H et al. (1997) Consistency of Doppler parameters in predicting arteriographically confirmed carotid stenosis. Asymptomatic Carotid Atherosclerosis Study Investigators. Stroke 28:343-7
Howard, G; Baker, W H; Chambless, L E et al. (1996) An approach for the use of Doppler ultrasound as a screening tool for hemodynamically significant stenosis (despite heterogeneity of Doppler performance). A multicenter experience. Asymptomatic Carotid Atherosclerosis Study Investigators. Stroke 27:1951-7
Moore, W S; Young, B; Baker, W H et al. (1996) Surgical results: a justification of the surgeon selection process for the ACAS trial. The ACAS Investigators. J Vasc Surg 23:323-8
Young, B; Moore, W S; Robertson, J T et al. (1996) An analysis of perioperative surgical mortality and morbidity in the asymptomatic carotid atherosclerosis study. ACAS Investigators. Asymptomatic Carotid Artheriosclerosis Study. Stroke 27:2216-24
Dean, B L; Lefkowitz, D S; Howard, V J et al. (1996) Comparison of centralized versus ""site-based"" measurement of angiographic stenosis for eligibility in the asymptomatic carotid atherosclerosis study. Invest Radiol 31:446-50

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