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
About this trial
This is an interventional treatment trial for Cardiovascular Diseases
Eligibility Criteria
Men and women, under 67 years old. Ischemic heart disease.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000489
First Posted
October 27, 1999
Last Updated
February 16, 2016
Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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
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Chaitman BR, Fisher LD, Bourassa MG, Davis K, Rogers WJ, Maynard C, Tyras DH, Berger RL, Judkins MP, Ringqvist I, Mock MB, Killip T. Effect of coronary bypass surgery on survival patterns in subsets of patients with left main coronary artery disease. Report of the Collaborative Study in Coronary Artery Surgery (CASS). Am J Cardiol. 1981 Oct;48(4):765-77. doi: 10.1016/0002-9149(81)90156-9.
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Mock MB, Ringqvist I, Fisher LD, Davis KB, Chaitman BR, Kouchoukos NT, Kaiser GC, Alderman E, Ryan TJ, Russell RO Jr, Mullin S, Fray D, Killip T 3rd. Survival of medically treated patients in the coronary artery surgery study (CASS) registry. Circulation. 1982 Sep;66(3):562-8. doi: 10.1161/01.cir.66.3.562.
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Fisher LD, Kennedy JW, Davis KB, Maynard C, Fritz JK, Kaiser G, Myers WO. Association of sex, physical size, and operative mortality after coronary artery bypass in the Coronary Artery Surgery Study (CASS). J Thorac Cardiovasc Surg. 1982 Sep;84(3):334-41.
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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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Lundberg ED, McBride R, Rawson TE, et al: A Data Base Management System Developed for the Coronary Artery Surgery Study (CASS) and other Clinical Studies. 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. Riddle K, Thurber P, Keen P, et al: l982 pp. 484-500.
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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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Frommer PL, Fisher LD, Mock MB, et al: The Coronary Artery Surgery Study: A Randomized Trial in the Context of the Registry. Ibid, 57-82, 1983.
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6863543
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Ringqvist I, Fisher LD, Mock M, Davis KB, Wedel H, Chaitman BR, Passamani E, Russell RO Jr, Alderman EL, Kouchoukas NT, Kaiser GC, Ryan TJ, Killip T, Fray D. Prognostic value of angiographic indices of coronary artery disease from the Coronary Artery Surgery Study (CASS). J Clin Invest. 1983 Jun;71(6):1854-66. doi: 10.1172/jci110941.
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Gersh BJ, Kronmal RA, Frye RL, Schaff HV, Ryan TJ, Gosselin AJ, Kaiser GC, Killip T 3rd. Coronary arteriography and coronary artery bypass surgery: morbidity and mortality in patients ages 65 years or older. A report from the Coronary Artery Surgery Study. Circulation. 1983 Mar;67(3):483-91. doi: 10.1161/01.cir.67.3.483.
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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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Holmes DR Jr, Vlietstra RE, Fisher LD, Smith HC, Mock MB, Faxon DP, Gosselin AJ, Ryan TJ, Judkins MP, Pettinger M. Follow-up of patients from the coronary artery surgery study (CASS) potentially suitable for percutaneous transluminal coronary angioplasty. Am Heart J. 1983 Nov;106(5 Pt 1):981-8. doi: 10.1016/0002-8703(83)90641-5.
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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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7471382
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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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Kennedy JW, Kaiser GC, Fisher LD, Fritz JK, Myers W, Mudd JG, Ryan TJ. Clinical and angiographic predictors of operative mortality from the collaborative study in coronary artery surgery (CASS). Circulation. 1981 Apr;63(4):793-802. doi: 10.1161/01.cir.63.4.793.
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3349585
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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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Holloway JD, Schocken DD. CASS in retrospect: lessons from the randomized cohort and registry. Coronary Artery Surgery Study. Am J Med Sci. 1988 May;295(5):424-32. doi: 10.1097/00000441-198805000-00003.
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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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Ellis SG, Fisher L, Dushman-Ellis S, Pettinger M, King SB 3rd, Roubin GS, Alderman E. Comparison of coronary angioplasty with medical treatment for single- and double-vessel coronary disease with left anterior descending coronary involvement: long-term outcome based on an Emory-CASS registry study. Am Heart J. 1989 Aug;118(2):208-20. doi: 10.1016/0002-8703(89)90178-6.
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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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Weiner DA, Ryan TJ, Parsons L, Fisher LD, Chaitman BR, Sheffield LT, Tristani FE. Significance of silent myocardial ischemia during exercise testing in women: report from the Coronary Artery Surgery Study. Am Heart J. 1995 Mar;129(3):465-70. doi: 10.1016/0002-8703(95)90269-4.
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Weiner DA, Ryan TJ, Parsons L, Fisher LD, Chaitman BR, Sheffield LT, Tristani FE. Long-term prognostic value of exercise testing in men and women from the Coronary Artery Surgery Study (CASS) registry. Am J Cardiol. 1995 May 1;75(14):865-70. doi: 10.1016/s0002-9149(99)80677-8.
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Davis KB, Chaitman B, Ryan T, Bittner V, Kennedy JW. Comparison of 15-year survival for men and women after initial medical or surgical treatment for coronary artery disease: a CASS registry study. Coronary Artery Surgery Study. J Am Coll Cardiol. 1995 Apr;25(5):1000-9. doi: 10.1016/0735-1097(94)00518-u.
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Rihal CS, Eagle KA, Mickel MC, Foster ED, Sopko G, Gersh BJ. Surgical therapy for coronary artery disease among patients with combined coronary artery and peripheral vascular disease. Circulation. 1995 Jan 1;91(1):46-53. doi: 10.1161/01.cir.91.1.46.
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Zimmerman FH, Cameron A, Fisher LD, Ng G. Myocardial infarction in young adults: angiographic characterization, risk factors and prognosis (Coronary Artery Surgery Study Registry). J Am Coll Cardiol. 1995 Sep;26(3):654-61. doi: 10.1016/0735-1097(95)00254-2.
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Cameron A, Davis KB, Green G, Schaff HV. Coronary bypass surgery with internal-thoracic-artery grafts--effects on survival over a 15-year period. N Engl J Med. 1996 Jan 25;334(4):216-9. doi: 10.1056/NEJM199601253340402.
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Loop FD. Internal-thoracic-artery grafts. Biologically better coronary arteries. N Engl J Med. 1996 Jan 25;334(4):263-5. doi: 10.1056/NEJM199601253340411. No abstract available.
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Taylor HA Jr, Mickel MC, Chaitman BR, Sopko G, Cutter GR, Rogers WJ. Long-term survival of African Americans in the Coronary Artery Surgery Study (CASS). J Am Coll Cardiol. 1997 Feb;29(2):358-64. doi: 10.1016/s0735-1097(96)00500-1.
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Myers WO, Blackstone EH, Davis K, Foster ED, Kaiser GC. CASS Registry long term surgical survival. Coronary Artery Surgery Study. J Am Coll Cardiol. 1999 Feb;33(2):488-98. doi: 10.1016/s0735-1097(98)00563-4. Erratum In: J Am Coll Cardiol 1999 Oct;34(4):1363.
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Barzilay JI, Kronmal RA, Bittner V, Eaker E, Evans C, Foster ED. Coronary artery disease in diabetic patients with lower-extremity arterial disease: disease characteristics and survival. A report from the Coronary Artery Surgery Study (CASS) registry. Diabetes Care. 1997 Sep;20(9):1381-7. doi: 10.2337/diacare.20.9.1381.
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Judge KW, Pawitan Y, Caldwell J, Gersh BJ, Kennedy JW. Congestive heart failure symptoms in patients with preserved left ventricular systolic function: analysis of the CASS registry. J Am Coll Cardiol. 1991 Aug;18(2):377-82. doi: 10.1016/0735-1097(91)90589-2.
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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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