Cardiovascular DiseasesPhase 3NCT00000489
Coronary Artery Surgery Study (CASS)
A Phase 3 study testing coronary artery bypass in people with Cardiovascular Diseases and Coronary Disease, run by University of Washington.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 66 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- What is being tested?
- coronary artery bypass
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 1973to Dec 1996
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Men and women, under 67 years old. Ischemic heart disease.
About this study
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.
Read the 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.
- Being tested
- coronary artery bypass
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary artery bypassProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startJun 1973
- Study completionDec 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (104)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Kathryn Davis, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000489
- Sponsor's protocol ID
- 8
- Other IDs
- R01HL038941
- Status last verified
- Dec 2005
- First submitted
- 27 Oct 1999
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
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.
PubMed 6391399Passamani E, Davis KB, Gillespie MJ, Killip T. A randomized trial of coronary artery bypass surgery. Survival of patients with a low ejection fraction. N Engl J Med. 1985 Jun 27;312(26):1665-71. doi: 10.1056/NEJM198506273122603.
PubMed 3873614Ryan 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.
PubMed 3905057Killip T. The coronary artery surgery study (CASS)--a randomized trial and a registry. Z Kardiol. 1985;74 Suppl 6:79-85.
PubMed 2869618Myers WO, Davis K, Foster ED, Maynard C, Kaiser GC. Surgical survival in the Coronary Artery Surgery Study (CASS) registry. Ann Thorac Surg. 1985 Sep;40(3):245-60. doi: 10.1016/s0003-4975(10)60037-9.
PubMed 3876085Davis KB, Fisher L, Gillespie MJ, Pettinger M. A test of the National Death Index using the Coronary Artery Surgery Study (CASS). Control Clin Trials. 1985 Sep;6(3):179-91. doi: 10.1016/0197-2456(85)90001-7.
PubMed 4042662Bourassa MG, Fisher LD, Campeau L, Gillespie MJ, McConney M, Lesperance J. Long-term fate of bypass grafts: the Coronary Artery Surgery Study (CASS) and Montreal Heart Institute experiences. Circulation. 1985 Dec;72(6 Pt 2):V71-8.
PubMed 3905060Killip T, Passamani E, Davis K. Coronary artery surgery study (CASS): a randomized trial of coronary bypass surgery. Eight years follow-up and survival in patients with reduced ejection fraction. Circulation. 1985 Dec;72(6 Pt 2):V102-9.
PubMed 3905050Kaiser GC, Davis KB, Fisher LD, Myers WO, Foster ED, Passamani ER, Gillespie MJ. Survival following coronary artery bypass grafting in patients with severe angina pectoris (CASS). An observational study. J Thorac Cardiovasc Surg. 1985 Apr;89(4):513-24.
PubMed 3884909Gersh BJ, Kronmal RA, Schaff HV, Frye RL, Ryan TJ, Mock MB, Myers WO, Athearn MW, Gosselin AJ, Kaiser GC, et al. Comparison of coronary artery bypass surgery and medical therapy in patients 65 years of age or older. A nonrandomized study from the Coronary Artery Surgery Study (CASS) registry. N Engl J Med. 1985 Jul 25;313(4):217-24. doi: 10.1056/NEJM198507253130403.
PubMed 3874368Vlietstra RE, Kronmal RA, Oberman A, Frye RL, Killip T 3rd. Effect of cigarette smoking on survival of patients with angiographically documented coronary artery disease. Report from the CASS registry. JAMA. 1986 Feb 28;255(8):1023-7.
PubMed 3945013Kemp HG, Kronmal RA, Vlietstra RE, Frye RL. Seven year survival of patients with normal or near normal coronary arteriograms: a CASS registry study. J Am Coll Cardiol. 1986 Mar;7(3):479-83. doi: 10.1016/s0735-1097(86)80456-9.
PubMed 3512658Foster ED, Davis KB, Carpenter JA, Abele S, Fray D. Risk of noncardiac operation in patients with defined coronary disease: The Coronary Artery Surgery Study (CASS) registry experience. Ann Thorac Surg. 1986 Jan;41(1):42-50. doi: 10.1016/s0003-4975(10)64494-3.
PubMed 3484621Holmes DR Jr, Davis KB, Mock MB, Fisher LD, Gersh BJ, Killip T 3rd, Pettinger M. The effect of medical and surgical treatment on subsequent sudden cardiac death in patients with coronary artery disease: a report from the Coronary Artery Surgery Study. Circulation. 1986 Jun;73(6):1254-63. doi: 10.1161/01.cir.73.6.1254.
PubMed 3486056Maynard C, Fisher LD, Passamani ER, Pullum T. Blacks in the Coronary Artery Surgery Study: risk factors and coronary artery disease. Circulation. 1986 Jul;74(1):64-71. doi: 10.1161/01.cir.74.1.64.
PubMed 3708780
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Surgery Study (CASS)
- ClinicalTrials.gov ID
- NCT00000489
- Acronym / sponsor ID
- 8
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 1973
- Study completion
- Dec 1996
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 21 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary artery bypass | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 6391399Foster 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.
- Background: PubMed 3873614Passamani E, Davis KB, Gillespie MJ, Killip T. A randomized trial of coronary artery bypass surgery. Survival of patients with a low ejection fraction. N Engl J Med. 1985 Jun 27;312(26):1665-71. doi: 10.1056/NEJM198506273122603.
- Background: PubMed 3905057Ryan 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.
- Background: PubMed 2869618Killip T. The coronary artery surgery study (CASS)--a randomized trial and a registry. Z Kardiol. 1985;74 Suppl 6:79-85.
- Background: PubMed 3876085Myers WO, Davis K, Foster ED, Maynard C, Kaiser GC. Surgical survival in the Coronary Artery Surgery Study (CASS) registry. Ann Thorac Surg. 1985 Sep;40(3):245-60. doi: 10.1016/s0003-4975(10)60037-9.
- Background: PubMed 4042662Davis KB, Fisher L, Gillespie MJ, Pettinger M. A test of the National Death Index using the Coronary Artery Surgery Study (CASS). Control Clin Trials. 1985 Sep;6(3):179-91. doi: 10.1016/0197-2456(85)90001-7.
- Background: PubMed 3905060Bourassa MG, Fisher LD, Campeau L, Gillespie MJ, McConney M, Lesperance J. Long-term fate of bypass grafts: the Coronary Artery Surgery Study (CASS) and Montreal Heart Institute experiences. Circulation. 1985 Dec;72(6 Pt 2):V71-8.
- Background: PubMed 3905050Killip T, Passamani E, Davis K. Coronary artery surgery study (CASS): a randomized trial of coronary bypass surgery. Eight years follow-up and survival in patients with reduced ejection fraction. Circulation. 1985 Dec;72(6 Pt 2):V102-9.
- Background: PubMed 3884909Kaiser GC, Davis KB, Fisher LD, Myers WO, Foster ED, Passamani ER, Gillespie MJ. Survival following coronary artery bypass grafting in patients with severe angina pectoris (CASS). An observational study. J Thorac Cardiovasc Surg. 1985 Apr;89(4):513-24.
- Background: PubMed 3874368Gersh BJ, Kronmal RA, Schaff HV, Frye RL, Ryan TJ, Mock MB, Myers WO, Athearn MW, Gosselin AJ, Kaiser GC, et al. Comparison of coronary artery bypass surgery and medical therapy in patients 65 years of age or older. A nonrandomized study from the Coronary Artery Surgery Study (CASS) registry. N Engl J Med. 1985 Jul 25;313(4):217-24. doi: 10.1056/NEJM198507253130403.
- Background: PubMed 3945013Vlietstra RE, Kronmal RA, Oberman A, Frye RL, Killip T 3rd. Effect of cigarette smoking on survival of patients with angiographically documented coronary artery disease. Report from the CASS registry. JAMA. 1986 Feb 28;255(8):1023-7.
- Background: PubMed 3512658Kemp HG, Kronmal RA, Vlietstra RE, Frye RL. Seven year survival of patients with normal or near normal coronary arteriograms: a CASS registry study. J Am Coll Cardiol. 1986 Mar;7(3):479-83. doi: 10.1016/s0735-1097(86)80456-9.
Related trials for Cardiovascular Diseases
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
RecruitingObservational study
Atrial Fibrillation Patients Treated With Catheter Ablation
Atrial Fibrillation, Atrial Fibrillation Recurrent
RecruitingPhase 1
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
AML, Multiple Myeloma
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
RecruitingPhase 2
A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel
Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Davis
University of Washington
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing coronary artery bypass in people with Cardiovascular Diseases and Coronary Disease, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000489, which also lists 104 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.