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Program on Surgical Control of Hyperlipidemias (POSCH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000490
First Posted: October 28, 1999
Last Update Posted: February 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
  Purpose
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.

Condition Intervention Phase
Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction Myocardial Ischemia Procedure: jejunoileal bypass Behavioral: diet, fat-restricted Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Study Start Date: June 1973
Estimated Study Completion Date: December 1997
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women, ages 30 to 64. Had one myocardial infarction. Had hyperlipoproteinemia.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000490


Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Henry Buchwald University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Long, JM, Brashear JR: Database Management for Clinical Trials. AFIPS Conference Proceedings: l977 National Computer Conference. AFIPS Press, Montvale, New Jersey, l977, 59-62.
Long, 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.
Buchwald 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: Intestinal Bypass for Hypercholesterolemia. In Nyhus LM (Ed.). Mastery of Surgery. Little Brown and Co., Vol II, 901-907, 1984.
Buchwald H: Partial Ileal Bypass: A Surgical Approach to Cholesterol Lowering. In Perspectives in Lipid Disorders. McGraw-Hill Pub. Co., New York, Vol. 3, 1985.
Long JM: The POSCH Secondary Intervention Trial. Proc Int Cong Prev Cardiology, Moscow, 1985.
Long JM: Discovery and Confirmation of Causal Relationships in a Large Medical Record Database: A POSCH Experiment. Society for Clinical Trials, Annual Conference, 1985.
Buchwald H, Fitch L, Varco RL: Partial Ileal Bypass; Hypercholesterolemia; Atherosclerosis. In Nyhus LM, Nelson RL (Eds.): Blackwell Scientific Publ Inc, Boston, MA, 1985, in press.
Irani EA, Matts JP, Long JM, Slagle JR, and the POSCH Group: Using Artificial Neural Nets for Statistical Discovery: Observations After Using Back-Propagation, Expert Systems, and Multiple Linear Regression on Clinical Trial Data. Complex Systems, 3:295-311, 1989.
Campos CT, Matts JP, Fitch LL, et al: Modification of Plasma Lipoproteins Following Partial Ileal Bypass. Five-Year Results of the Program of the Surgical Control of the Hyperlipidemias. In: Atherosclerosis VIII, Proceedings of the 8th International Symposium on Atherosclerosis, Rome, 9-13, October 1988; G. Crepaldi et al, (Eds), Elsevier Science Publishers B.V., Amsterdam, pp 769-774, 1989.
Buchwald H, Campos CT: Partial Ileal Bypass for Control of Hyperlipidemia and Atherosclerosis. Chapter in: Gibbon's Surgery of the Chest, Fifth Edition; Sabiston DC Jr., Spencer FC (Eds); W.B. Saunders Company, Philadelphia, PA, pp 1799-1820, 1990.
Buchwald H, Campos CT, and the POSCH Group: Preliminary Results of the Program on the Surgical Control of the Hyperlipidemias (POSCH). Chapter in: Proceedings of the 7th International Atherosclerosis and Cardiovascular Disease Meeting. Dordrecht: Kluwer Academic Publishers, in press, 1990.
Campos CT, Buchwald H, and the POSCH Group: The Program on the Surgical Control of the Hyperlipidemias (POSCH): Demonstration of the Beneficial Effects of Treatment of Hypercholesterolemia. Cardiovasc Risk Factors, 2:261-275, 1992.

ClinicalTrials.gov Identifier: NCT00000490     History of Changes
Other Study ID Numbers: 9
R01HL049522 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: February 25, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Ischemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Pathologic Processes
Necrosis
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases