Systematic Management of High Cholesterol Utilizing Computer Monitoring

NCT00133094 | Completed

• 2 other identifiers: XVA 72-02900262
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Employing a physician-directed case management system, utilizing a Certified Registered Nurse Practitioner (CRNP) in conjunction with computer-based decision support technology (CDST) will result in significantly lower total cholesterol and a lower low density lipoprotein cholesterol in a group of subjects enrolled in a general medical clinic compared to subjects managed by primary care providers in the usual care group.

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemia; Decision Support Systems, Clinical

Outcome Measures

Primary Outcomes (1)

• Total cholesterol and LDL-C cholesterol lowering

Secondary Outcomes (1)

• Verification that the decision support program provides equivalent recommendations for management of elevated cholesterol as would an expert in the management of hypercholesterolemia

Study Arms (1)

Arm 1

OTHER

Drug: Simvastin; Procedure: Computer-based decision support technology

Interventions

Simvastin DRUG

Arm 1

Computer-based decision support technology PROCEDURE

Arm 1

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of atherosclerosis and/or diabetes mellitus
• Males age 45-70
• Females age 55-70, at least 1 year post-menopausal
• No contraindication to HMG-Co A inhibitor therapy
• No administration of lipid lowering agents, except simvistatin less than or equal to 10 mg/day
• TSH level greater than 0.34 and less than 5.6 IU
• Urine protein less than or equal to 300 mg%
• Lipid profile consistent with Fredrickson type hyperlipidemia: total cholesterol greater than or equal to 140 mg% and less than or equal to 300 mg%; LDL-C greater than or equal to 100 mg%; and triglycerides less than 400 mg%
• Normal liver function tests (SGOT \< 42 IU; SGPT \<60 IU and CPK \<269 IU)
• One of the following diagnoses which establishes the presence atherosclerosis, making the subjects candidates for secondary prevention of complications or the presence of diabetes mellitus, which is considered an atherosclerotic equivalent according to the NECP III guidelines: uncomplicated acute myocardial infarction, more than 6 weeks previously; coronary arteriosclerosis (native artery and bypass grafts); prior aortocoronary bypass; prior PTCA; angina pectoris; peripheral vascular disease; or diabetes mellitus

You may not qualify if:

• \) Women of childbearing age (2) Chronic liver disease and cirrhosis (3) Viral hepatitis, with residual hepatic dysfunction (4) Active alcohol abuse or dependence within the preceding 3 years (5) Drug abuse with or with out dependence within the preceding 3 years (6) Malignant neoplasms (7) Stroke (8) Dementia (9) Parkinson�s Disease (10) Multiple sclerosis (11) Triglycerides greater than or equal to 400 mg% (12) Other contra-indication to HMG-Co A administration such as cocomitant administration of drugs with known adverse interactions with simvastatin such as amiodarone, cimetidine, cyclosporin, tacrolimus, fibrates, HIV protease inhibitors, nefazodone, erythromycin, telithromycin clarithromycin, verpramil, itraconazole, ketoconozole, fluconazole danazol, or large quantities of grapefruit juice greater than 1 qt/day (13) Concurrent administration of lipid lowering agents or simvastatin at a dose greater than 10 mg/day at the time of entry into the protocol (14) Hypertension with systolic blood pressure \>180 mm Hg or diastolic blood pressure \>100 mm Hg with or without treatment (15) Any chronic illness in which the life expectancy is \<3 years such as oxygen-dependent COPD

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• University of Pittsburgh: collaborator

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Links

• Click here for more information about this study: Management of Hypercholesterolemia Utilizing a Case Management System, Incorporating Computer-Based Decision Support Technology

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mark Ewing Thompson, MD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2005
• First Posted: August 22, 2005
• Study Start: June 1, 2006
• Study Completion: December 1, 2007
• Last Updated: April 7, 2015

Record last verified: 2007-12

Locations

US (1)