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Coronary Artery Surgery Study (CASS)

Primary Purpose

Cardiovascular Diseases, Coronary Disease, Heart Diseases

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
coronary artery bypass
Sponsored by
University of Washington
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases

Eligibility Criteria

21 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Men and women, under 67 years old. Ischemic heart disease.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    February 16, 2016
    Sponsor
    University of Washington
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000489
    Brief Title
    Coronary Artery Surgery Study (CASS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1973 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 1996 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Washington
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To compare coronary artery surgery with medical management in patients with coronary artery disease and to maintain a registry on all patients undergoing coronary arteriography, whether operatively or medically managed.
    Detailed Description
    BACKGROUND: Although it was generally agreed that many patients with severe angina pectoris improved symptomatically after coronary artery surgery, there was less consensus concerning, for example, other effects of the procedure, such as its long-term benefit and the criteria for patient selection. In addition, there were fewer data and less agreement on the effects and proper role of this procedure in other clinical circumstances. Both the surgical procedure and the prior diagnostic procedures represented substantial costs in both monetary and manpower terms; moreover, they entailed morbidity and mortality risks. There existed an urgent need for reliable and quantitative information regarding the effects of coronary artery surgery in patients with ischemic heart disease. To be meaningful, these data had to be set into the perspective of the clinical course of such patients under medical treatment. This assessment presupposed a meaningful classification of these patients and of the therapeutic interventions as well as evaluations of the effects of surgical and medical regimens in terms of mortality, the quality of life, and objective hemodynamic and other physiological measurements. Only such information could provide sufficient background for determining the suitability of coronary artery surgery for a particular patient. In 1972, the National Heart and Lung Advisory Council identified these questions as topics of high priority, and the National Heart and Lung Institute established an Ad Hoc Policy Advisory Board on Coronary Artery Surgery to assist it in developing a program of research activities. In its report, the Board noted a 'critical need for objective data on the long- and short-term effects of coronary artery surgery.' Requests for proposals were issued to carry out the recommendations of the Board. Planning of the trial was conducted between June 1973 and April 1975 and included protocol design, the development of a manual of operations, and a pilot study of the registry. In August 1975, registry patients' entry and randomization began at the 11 clinical centers and coordinating center. Initial projections of patient population numbers were underestimated; therefore, five clinical centers were added to the trial in 1976. The five clinical subgroups of patients in the randomized studies included: stable angina with normal resting left ventricular function; stable angina with impaired left ventricular function; post-myocardial infarction without angina; congestive heart failure due primarily to ischemic heart disease; and patients previously asymptomatic who were discovered to have serious coronary artery disease. All of the above subgroups must have met specifically outlined clinical and angiographic criteria to be placed in the randomized subset. The other two subsets (as distinguished from subgroups) of the study included those patients who were unsuitable for randomization because surgery was the treatment of choice in the judgment of many physicians and those patients for whom medical management was the treatment of choice. The patients enrolled in both the registry and randomized trial were followed for a 10-year period. This allowed evaluation of the primary endpoints, death and myocardial infarction, and the secondary endpoints, angina, status, and quality of life. A total of 24,959 patients were entered into the registry; 780 patients were entered into the trial. Recruitment ended in 1979. Intervention ended in June 1983. Follow-up was extended for an additional five years to June 1989. Data analysis continued through May 1995 with grant support. DESIGN NARRATIVE: Randomized, non-blind, sequential. Some 780 patients meeting the criteria of specific subsets based on history, physical exam, laboratory tests, catheterization, and angiography were randomized to either surgical or medical therapy. Primary endpoints included death and myocardial infarction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    coronary artery bypass

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    66 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Men and women, under 67 years old. Ischemic heart disease.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kathryn Davis
    Organizational Affiliation
    University of Washington

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    6391399
    Citation
    Foster ED, Fisher LD, Kaiser GC, Myers WO. Comparison of operative mortality and morbidity for initial and repeat coronary artery bypass grafting: The Coronary Artery Surgery Study (CASS) registry experience. Ann Thorac Surg. 1984 Dec;38(6):563-70. doi: 10.1016/s0003-4975(10)62312-0.
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    Ryan TJ, Weiner DA, McCabe CH, Davis KB, Sheffield LT, Chaitman BR, Tristani FE, Fisher LD. Exercise testing in the Coronary Artery Surgery Study randomized population. Circulation. 1985 Dec;72(6 Pt 2):V31-8.
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    Citation
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    Berger RL, Davis KB, Kaiser GC, Foster ED, Hammond GL, Tong TG, Kennedy JW, Sheffield T, Ringqvist I, Wiens RD, Chaitman BR, Mock M. Preservation of the myocardium during coronary artery bypass grafting. Circulation. 1981 Aug;64(2 Pt 2):II61-6.
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    Fisher LD, Lundberg ED, McBride R, et al: The Design of a Database Management System, C2, for Research Use in the Coronary Artery Surgery Study (CASS). Proceedings of the Fifteenth Hawaii International Conference on Systems Sciences, l982, Volume II, Software, Hardware, Decision Support Systems, Special Topics. Western Periodicals Co., North Hollywood, CA. Ed.W.
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    Vlietstra RE, Kronmal RA, Frye RL, Seth AK, Tristani FE, Killip T 3rd. Factors affecting the extent and severity of coronary artery disease in patients enrolled in the coronary artery surgery study. Arteriosclerosis. 1982 May-Jun;2(3):208-15. doi: 10.1161/01.atv.2.3.208.
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    Alderman EL, Fisher L, Maynard C, Mock MB, Ringqvist I, Bourassa MG, Kaiser GC, Gillespie MJ. Determinants of coronary surgery in a consecutive patient series from geographically dispersed medical centers. The coronary artery surgery study. Circulation. 1982 Aug;66(2 Pt 2):I6-15.
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    Davis KB, Kennedy JW, Berger RL, et al: Operative Mortality in the CASS Registry. Coronary Bypass Surgery, New York, Praeger Scientific. 99-127, 1983.
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    Davis KB, Chaitman BR, Killip T, et al: Effect of Coronary Bypass Surgery on Operative Mortality and Survival Patterns in Subsets of Patients with Left Main Coronary Artery Disease. In Hammermeister KE (Ed): Coronary Bypass Surgery, New York, Praeger Scientific, 99-127, 1983.
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    Ryan TJ, Bailey KR, McCabe CH, Luk S, Fisher LD, Mock MB, Killip T. The effects of digitalis on survival in high-risk patients with coronary artery disease. The Coronary Artery Surgery Study (CASS). Circulation. 1983 Apr;67(4):735-42. doi: 10.1161/01.cir.67.4.735. No abstract available.
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    Coronary artery surgery study (CASS): a randomized trial of coronary artery bypass surgery. Survival data. Circulation. 1983 Nov;68(5):939-50. doi: 10.1161/01.cir.68.5.939.
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    Coronary artery surgery study (CASS): a randomized trial of coronary artery bypass surgery. Quality of life in patients randomly assigned to treatment groups. Circulation. 1983 Nov;68(5):951-60. doi: 10.1161/01.cir.68.5.951.
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    Chaitman BR, Davis K, Fisher LD, Bourassa MG, Mock MB, Lesperance J, Rogers WJ, Fray D, Tyras DH, Judkins MP, et al. A life table and Cox regression analysis of patients with combined proximal left anterior descending and proximal left circumflex coronary artery disease: non-left main equivalent lesions (CASS). Circulation. 1983 Dec;68(6):1163-70. doi: 10.1161/01.cir.68.6.1163.
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    Coronary artery surgery study (CASS): a randomized trial of coronary artery bypass surgery. Comparability of entry characteristics and survival in randomized patients and nonrandomized patients meeting randomization criteria. J Am Coll Cardiol. 1984 Jan;3(1):114-28.
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    Cameron AA, Davis KB, Rogers WJ. Recurrence of angina after coronary artery bypass surgery: predictors and prognosis (CASS Registry). Coronary Artery Surgery Study. J Am Coll Cardiol. 1995 Oct;26(4):895-9. doi: 10.1016/0735-1097(95)00280-4.
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    Fisher LD, Kennedy JW, Chaitman BR, Ryan TJ, McCabe C, Weiner D, Tristani F, Schloss M, Warner HR Jr. Diagnostic quantification of CASS (coronary artery surgery study) clinical and exercise test results in determining presence and extent of coronary artery disease. A multivariate approach. Circulation. 1981 May;63(5):987-1000. doi: 10.1161/01.cir.63.5.987.
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    Bruce RA, Fisher LD, Pettinger M, Weiner DA, Chaitman BR. ST segment elevation with exercise: a marker for poor ventricular function and poor prognosis. Coronary Artery Surgery Study (CASS) confirmation of Seattle Heart Watch results. Circulation. 1988 Apr;77(4):897-905. doi: 10.1161/01.cir.77.4.897.
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    Buffington CW, Davis KB, Gillispie S, Pettinger M. The prevalence of steal-prone coronary anatomy in patients with coronary artery disease: an analysis of the Coronary Artery Surgery Study Registry. Anesthesiology. 1988 Nov;69(5):721-7. doi: 10.1097/00000542-198811000-00014.
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    Zack PM, Chaitman BR, Davis KB, Kaiser GC, Wiens RD, Ng G. Survival patterns in clinical and angiographic subsets of medically treated patients with combined proximal left anterior descending and proximal left circumflex coronary artery disease (CASS). Am Heart J. 1989 Aug;118(2):220-7. doi: 10.1016/0002-8703(89)90179-8.
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    Emond M, Mock MB, Davis KB, Fisher LD, Holmes DR Jr, Chaitman BR, Kaiser GC, Alderman E, Killip T 3rd. Long-term survival of medically treated patients in the Coronary Artery Surgery Study (CASS) Registry. Circulation. 1994 Dec;90(6):2645-57. doi: 10.1161/01.cir.90.6.2645.
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    CASS Principal Investigators and Their Associates. Myocardial infarction and mortality in the coronary artery surgery study (CASS) randomized trial. N Engl J Med. 1984 Mar 22;310(12):750-8. doi: 10.1056/NEJM198403223101204.
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