Status:
COMPLETED
Reducing Risk Factors in Peripheral Arterial Disease
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Peripheral Vascular Diseases
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare a health-counselor mediated telephone counseling intervention to usual care to reduce low density lipoprotein cholesterol (LDL-C) levels in patients with periph...
Detailed Description
BACKGROUND: Patients with PAD have a 3- to 4-fold higher risk of cardiovascular morbidity and mortality compared to patients without PAD. Risk of future cardiovascular events is comparable between pa...
Eligibility Criteria
Inclusion
- Life expectancy greater than 1 year
- Has a telephone
- English-speaking
- Willing to use acceptable methods of contraception
- Have a primary care physician
Exclusion
- Currently undergoing cancer treatment or plans to begin treatment
- Psychiatric illness or cognitive impairment
- Intolerance to two or more cholesterol-lowering drugs
- Plans to move out of the area within one year of study entry
- Wheel-chair bound or unable to walk outside of home
- Below- or above-knee amputation
- Unstable angina
- Current foot ulcers
- LDL-C less than 70 mg/dl at baseline
- Debilitating chronic obstructive lung disease
- Major surgery within 3 months prior to study entry or plans to undergo major surgery within 1 year of study entry
- Current participation in another clinical trial. A six month period will be required after completing another clinical trial before an individual can become eligible for the current trial.
- Ischemic rest pain
- Pregnancy or plan to become pregnant
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT00217919
Start Date
February 1 2006
End Date
November 1 2009
Last Update
April 9 2014
Active Locations (2)
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1
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611
2
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655