Cardiovascular DiseasesPhase 3NCT00000490
Program on Surgical Control of Hyperlipidemias (POSCH)
A Phase 3 study testing jejunoileal bypass and diet, fat-restricted in people with Cardiovascular Diseases and Coronary Disease, run by University of Minnesota.
Trial summary
To determine whether a profound reduction in serum cholesterol level, induced and maintained by partial ileal bypass, would prevent a second heart attack among men and women who had one myocardial infarction and whose blood cholesterol could not be reduced sufficiently by diet. Read more about this study
- Who is it for?
- Ages 30 to 64 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- What is being tested?
- jejunoileal bypass and diet, fat-restricted
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 1973to Dec 1997
- 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 30 to 64 years
- All sexes
- No healthy volunteers
- Adult
Men and women, ages 30 to 64. Had one myocardial infarction. Had hyperlipoproteinemia.
About this study
To determine whether a profound reduction in serum cholesterol level, induced and maintained by partial ileal bypass, would prevent a second heart attack among men and women who had one myocardial infarction and whose blood cholesterol could not be reduced sufficiently by diet.
Read the detailed description
BACKGROUND:
The correlative evidence linking elevated cholesterol to increased risk of cardiovascular disease is incontrovertible. Animal studies have shown that significant reductions in disease in humans may be forthcoming if blood lipids are reduced from elevated levels. Beginning in the 1960s, some patients had undergone a surgical bypass procedure for hyperlipidemia. Patients were selected for surgery after dietary management had been carried out for three years. The average serum cholesterol concentrations decreased markedly and the decrease was sustained.
This grant-supported clinical trial attempted to determine the effect on cardiovascular morbidity and mortality of the partial ileal bypass in patients who had suffered a myocardial infarction within the previous 5 years and who had serum cholesterol over 220 mg deciliter (200 mg if LDL cholesterol was over l40 mg).
DESIGN NARRATIVE:
Randomized, non-blind, fixed sample study with a control group and an experimental group of equal size. The experimental group received a partial ileal bypass and diet therapy to reduce serum cholesterol and triglycerides. The control group was given conventional medical therapy exclusive of cholesterol-lowering drugs. The primary endpoint was death due to any cause. Secondary endpoints included death due to atherosclerosis and morbidity from recurrent myocardial infarction, unstable angina, cerebrovascular accident. Other secondary endpoints included coronary artery bypass surgery, percutaneous transluminal coronary angioplasty, cardiac transplantation, and peripheral vascular surgery.
Beginning in January 1993, long-term morbidity and mortality follow-up are continuing through December 1997 under grant support (R01HL49522). Follow-up includes tracking morbidity and mortality by an annual telephone survey and review of patient records, including death and autopsy results. In addition, mortality and morbidity will be correlated with lipid changes and existing arteriographic results. The long-term course of control patients treated with the AHA Phase II Diet counseling will be assessed and the long-term side effects of partial ileal bypass will be evaluated.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
- Being tested
- jejunoileal bypass, diet, fat-restricted
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
jejunoileal bypassProcedure or surgery
diet, fat-restrictedBehavioural
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 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Henry Buchwald, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000490
- Sponsor's protocol ID
- 9
- Other IDs
- R01HL049522
- Status last verified
- Feb 2016
- First submitted
- 27 Oct 1999
- Last updated
- 25 Feb 2016
- Results posted
- No
Publications
Buchwald H, Bourdages HR, Campos CT, Nguyen P, Williams SE, Boen JR. Impact of cholesterol reduction on peripheral arterial disease in the Program on the Surgical Control of the Hyperlipidemias (POSCH). Surgery. 1996 Oct;120(4):672-9. doi: 10.1016/s0039-6060(96)80016-x.
PubMed 8862377Buchwald H, Campos CT, Boen JR, Nguyen P, Williams SE, Lau J, Chalmers TC. Gender-based mortality follow-up from the Program on the Surgical Control of the Hyperlipidemias (POSCH) and meta-analysis of lipid intervention trials. Women in POSCH and other lipid trials. Ann Surg. 1996 Oct;224(4):486-98; discussion 498-500. doi: 10.1097/00000658-199610000-00007.
PubMed 8857853Long, JM, Brashear JR: Database Management for Clinical Trials. AFIPS Conference Proceedings: l977 National Computer Conference. AFIPS Press, Montvale, New Jersey, l977, 59-62.
Buchwald H, Moore RB, Varco RL. Maximum lipid reduction by partial ileal bypass: a test of the lipid-atherosclerosis hypothesis. Lipids. 1977 Jan;12(1):53-8. doi: 10.1007/BF02532972.
PubMed 834123Long, JM, Brashear JR: Experience Using Standard Software to Provide a Comprehensive Information Processing System for a Large and Complex Clinical Study. Proceedings of the Second Annual Symposium on Computer Application in Medical Care. IEEE, New York, New York, l978, 563-565.
Jelovsek FR, Bolinger RE, Davis RE, et al: Guidelines for User Access to Computerized Medical Records. J Med Systems, 2:24l-248, l978.
Matts JP, McHugh RB. Analysis of accrual randomized clinical trials with balanced groups in strata. J Chronic Dis. 1978;31(12):725-40. doi: 10.1016/0021-9681(78)90057-7. No abstract available.
PubMed 748369Moore RB, Long JM, Matts JP, Amplatz K, Varco RL, Buchwald H. Plasma lipoproteins and coronary arteriography in subjects in the program on the surgical control of the hyperlipidemias. Preliminary report. Atherosclerosis. 1979 Feb;32(2):101-19. doi: 10.1016/0021-9150(79)90076-5.
PubMed 222301Moore RB, Buchwald H, Varco RL. The effect of partial ileal bypass on plasma lipoproteins. Circulation. 1980 Sep;62(3):469-76. doi: 10.1161/01.cir.62.3.469.
PubMed 7398005Long JM, Brashear JR, Matts JP, Bearman JE. The POSCH Information Management System: experience with alternative approaches. J Med Syst. 1980;4(3-4):355-66. doi: 10.1007/BF02222845.
PubMed 7264481Buchwald H, Moore RB, Matts JP, Long JM, Varco RL, Campbell GS, Pearce MB, Yellin AE, Blankenhorn DH, Holmes WL, Smink RD Jr, Sawin HS Jr. The Program on the Surgical Control of the Hyperlipidemias: a status report. Surgery. 1982 Oct;92(4):654-62.
PubMed 6750834Buchwald H, Rucker RD Jr., Moore RB, et al: Regression of Atherosclerosis by Surgical Cholesterol Reduction. In Noseda G et al (Eds): Lipoproteins and Coronary Atherosclerosis. Elsevier Biomedical Press, 417, 1982.
Buchwald H, Moore RB, Varco, RL: Surgery in the Therapy of Atherosclerosis: Partial Ileal Bypass. In Atherosclerosis: Clinical Evaluation and Therapy. MTP Press Limited, International Medical Publication, 1982.
Long JM, Brashear JR, Matts JP, et al: The Evolution of a Large Clinical Database. Proceedings of Medcomp, 82:224-229, 1982.
Buchwald H, Fitch L, Moore RB. Overview of randomized clinical trials of lipid intervention for atherosclerotic cardiovascular disease. Control Clin Trials. 1982 Sep;3(3):271-83. doi: 10.1016/0197-2456(82)90011-3.
PubMed 6759035
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program on Surgical Control of Hyperlipidemias (POSCH)
- ClinicalTrials.gov ID
- NCT00000490
- Acronym / sponsor ID
- 9
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 1973
- Study completion
- Dec 1997
- 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 determine whether a profound reduction in serum cholesterol level, induced and maintained by partial ileal bypass, would prevent a second heart attack among men and women who had one myocardial infarction and whose blood cholesterol could not be reduced sufficiently by diet.
Detailed description
BACKGROUND:
The correlative evidence linking elevated cholesterol to increased risk of cardiovascular disease is incontrovertible. Animal studies have shown that significant reductions in disease in humans may be forthcoming if blood lipids are reduced from elevated levels. Beginning in the 1960s, some patients had undergone a surgical bypass procedure for hyperlipidemia. Patients were selected for surgery after dietary management had been carried out for three years. The average serum cholesterol concentrations decreased markedly and the decrease was sustained.
This grant-supported clinical trial attempted to determine the effect on cardiovascular morbidity and mortality of the partial ileal bypass in patients who had suffered a myocardial infarction within the previous 5 years and who had serum cholesterol over 220 mg deciliter (200 mg if LDL cholesterol was over l40 mg).
DESIGN NARRATIVE:
Randomized, non-blind, fixed sample study with a control group and an experimental group of equal size. The experimental group received a partial ileal bypass and diet therapy to reduce serum cholesterol and triglycerides. The control group was given conventional medical therapy exclusive of cholesterol-lowering drugs. The primary endpoint was death due to any cause. Secondary endpoints included death due to atherosclerosis and morbidity from recurrent myocardial infarction, unstable angina, cerebrovascular accident. Other secondary endpoints included coronary artery bypass surgery, percutaneous transluminal coronary angioplasty, cardiac transplantation, and peripheral vascular surgery.
Beginning in January 1993, long-term morbidity and mortality follow-up are continuing through December 1997 under grant support (R01HL49522). Follow-up includes tracking morbidity and mortality by an annual telephone survey and review of patient records, including death and autopsy results. In addition, mortality and morbidity will be correlated with lipid changes and existing arteriographic results. The long-term course of control patients treated with the AHA Phase II Diet counseling will be assessed and the long-term side effects of partial ileal bypass will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| jejunoileal bypass | Procedure or surgery | – |
| diet, fat-restricted | Behavioural | – |
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 25 Feb 2016.
- Background: PubMed 8862377Buchwald H, Bourdages HR, Campos CT, Nguyen P, Williams SE, Boen JR. Impact of cholesterol reduction on peripheral arterial disease in the Program on the Surgical Control of the Hyperlipidemias (POSCH). Surgery. 1996 Oct;120(4):672-9. doi: 10.1016/s0039-6060(96)80016-x.
- Background: PubMed 8857853Buchwald H, Campos CT, Boen JR, Nguyen P, Williams SE, Lau J, Chalmers TC. Gender-based mortality follow-up from the Program on the Surgical Control of the Hyperlipidemias (POSCH) and meta-analysis of lipid intervention trials. Women in POSCH and other lipid trials. Ann Surg. 1996 Oct;224(4):486-98; discussion 498-500. doi: 10.1097/00000658-199610000-00007.
- BackgroundLong, JM, Brashear JR: Database Management for Clinical Trials. AFIPS Conference Proceedings: l977 National Computer Conference. AFIPS Press, Montvale, New Jersey, l977, 59-62.
- Background: PubMed 834123Buchwald H, Moore RB, Varco RL. Maximum lipid reduction by partial ileal bypass: a test of the lipid-atherosclerosis hypothesis. Lipids. 1977 Jan;12(1):53-8. doi: 10.1007/BF02532972.
- BackgroundLong, JM, Brashear JR: Experience Using Standard Software to Provide a Comprehensive Information Processing System for a Large and Complex Clinical Study. Proceedings of the Second Annual Symposium on Computer Application in Medical Care. IEEE, New York, New York, l978, 563-565.
- BackgroundJelovsek FR, Bolinger RE, Davis RE, et al: Guidelines for User Access to Computerized Medical Records. J Med Systems, 2:24l-248, l978.
- Background: PubMed 748369Matts JP, McHugh RB. Analysis of accrual randomized clinical trials with balanced groups in strata. J Chronic Dis. 1978;31(12):725-40. doi: 10.1016/0021-9681(78)90057-7. No abstract available.
- Background: PubMed 222301Moore RB, Long JM, Matts JP, Amplatz K, Varco RL, Buchwald H. Plasma lipoproteins and coronary arteriography in subjects in the program on the surgical control of the hyperlipidemias. Preliminary report. Atherosclerosis. 1979 Feb;32(2):101-19. doi: 10.1016/0021-9150(79)90076-5.
- Background: PubMed 7398005Moore RB, Buchwald H, Varco RL. The effect of partial ileal bypass on plasma lipoproteins. Circulation. 1980 Sep;62(3):469-76. doi: 10.1161/01.cir.62.3.469.
- Background: PubMed 7264481Long JM, Brashear JR, Matts JP, Bearman JE. The POSCH Information Management System: experience with alternative approaches. J Med Syst. 1980;4(3-4):355-66. doi: 10.1007/BF02222845.
- Background: PubMed 6750834Buchwald H, Moore RB, Matts JP, Long JM, Varco RL, Campbell GS, Pearce MB, Yellin AE, Blankenhorn DH, Holmes WL, Smink RD Jr, Sawin HS Jr. The Program on the Surgical Control of the Hyperlipidemias: a status report. Surgery. 1982 Oct;92(4):654-62.
- BackgroundBuchwald H, Rucker RD Jr., Moore RB, et al: Regression of Atherosclerosis by Surgical Cholesterol Reduction. In Noseda G et al (Eds): Lipoproteins and Coronary Atherosclerosis. Elsevier Biomedical Press, 417, 1982.
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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.
Henry Buchwald
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing jejunoileal bypass and diet, fat-restricted in people with Cardiovascular Diseases and Coronary Disease, run by University of Minnesota.
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 25 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 NCT00000490, which also lists 63 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 25 Feb 2016; AzTrials last refreshed its copy on 30 Oct 2026.