Etiology and Prevalence of Peripheral Arterial Disease
Primary Purpose
Cardiovascular Diseases, Peripheral Vascular Diseases, Arterial Occlusive Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005142
First Posted
May 25, 2000
Last Updated
February 26, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005142
Brief Title
Etiology and Prevalence of Peripheral Arterial Disease
Study Type
Observational
2. Study Status
Record Verification Date
June 2000
Overall Recruitment Status
Completed
Study Start Date
July 1978 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 1990 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To determine the prevalence of peripheral arterial disease in a defined population by non-invasive techniques; to evaluate the association of cardiovascular disease risk factors with peripheral vascular disease; to determine whether non-invasive tests of peripheral arterial disease can be utilized as markers for coronary heart disease; to determine the status of the microvasculature using conjunctival photographs and to compare the results with risk factors and the peripheral arterial disease testing results.
Detailed Description
BACKGROUND:
Atherosclerosis is frequently generalized, affecting blood vessels in various parts of the body. Previous studies had noted the strong association between peripheral arterial disease and coronary heart disease and the similarity of risk factors, particularly diabetes and cigarette smoking for both diseases. The natural history of peripheral arterial disease had not been delineated because of the lack, until recently, of accurate and reliable non-invasive testing.
DESIGN NARRATIVE:
All 624 subjects were initially studied under a Lipid Research Clinic protocol that involved two evaluations, visit 1 and visit 2. At visit 2, half of the subjects were from a random sample of the LRC visit 1 cohort and others were selected from the visit 1 cohort for hyperlipidemia, defined as being at or above age- and sex-specific 90th percentiles for cholesterol or 95th percentiles for triglycerides or taking lipid-lowering medications. At visit 2, the subjects were characterized as to age; sex; drug, diet, alcohol and smoking history; personal and family history of cardiovascular disease; Rose questionnaire; and electrocardiogram and examination by a cardiologist. The subjects were given a traditional manual examination for peripheral arterial disease and four non-invasive tests including segmental blood pressure, flow velocity by Doppler ultrasound, postocclusive reactive hyperemia, and pulse reappearance half-time. The subjects were categorized into large vessel peripheral arterial disease, isolated small vessel peripheral arterial disease or normal based on the results of non-invasive testing and followed for an average of four years.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Peripheral Vascular Diseases, Arterial Occlusive Diseases
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
3156006
Citation
Criqui MH, Fronek A, Barrett-Connor E, Klauber MR, Gabriel S, Goodman D. The prevalence of peripheral arterial disease in a defined population. Circulation. 1985 Mar;71(3):510-5. doi: 10.1161/01.cir.71.3.510.
Results Reference
background
PubMed Identifier
3156007
Citation
Criqui MH, Fronek A, Klauber MR, Barrett-Connor E, Gabriel S. The sensitivity, specificity, and predictive value of traditional clinical evaluation of peripheral arterial disease: results from noninvasive testing in a defined population. Circulation. 1985 Mar;71(3):516-22. doi: 10.1161/01.cir.71.3.516.
Results Reference
background
PubMed Identifier
4048078
Citation
Baker LL, Criqui MH. High- and low-density lipoprotein cholesterol: correlates in an older population. Prev Med. 1985 Mar;14(2):155-64. doi: 10.1016/0091-7435(85)90030-1.
Results Reference
background
PubMed Identifier
4028377
Citation
Criqui MH, Coughlin SS, Fronek A. Noninvasively diagnosed peripheral arterial disease as a predictor of mortality: results from a prospective study. Circulation. 1985 Oct;72(4):768-73. doi: 10.1161/01.cir.72.4.768.
Results Reference
background
PubMed Identifier
3728443
Citation
Standeven M, Criqui MH, Klauber MR, Gabriel S, Barrett-Connor E. Correlates of change in postmenopausal estrogen use in a population-based study. Am J Epidemiol. 1986 Aug;124(2):268-74. doi: 10.1093/oxfordjournals.aje.a114385.
Results Reference
background
PubMed Identifier
3813976
Citation
Barrett-Connor E, Criqui MH, Witztum JL, Philippi T, Zettner A. Population-based study of glycosylated hemoglobin, lipids, and lipoproteins in nondiabetic adults. Arteriosclerosis. 1987 Jan-Feb;7(1):66-70. doi: 10.1161/01.atv.7.1.66.
Results Reference
background
PubMed Identifier
3578366
Citation
Criqui MH, Lee ER, Hamburger RN, Klauber MR, Coughlin SS. IgE and cardiovascular disease. Results from a population-based study. Am J Med. 1987 May;82(5):964-8. doi: 10.1016/0002-9343(87)90159-8.
Results Reference
background
PubMed Identifier
2786328
Citation
Criqui MH, Browner D, Fronek A, Klauber MR, Coughlin SS, Barrett-Connor E, Gabriel S. Peripheral arterial disease in large vessels is epidemiologically distinct from small vessel disease. An analysis of risk factors. Am J Epidemiol. 1989 Jun;129(6):1110-9. doi: 10.1093/oxfordjournals.aje.a115233.
Results Reference
background
PubMed Identifier
1726213
Citation
Criqui MH, Langer RD, Fronek A, Feigelson HS. Coronary disease and stroke in patients with large-vessel peripheral arterial disease. Drugs. 1991;42 Suppl 5:16-21. doi: 10.2165/00003495-199100425-00005.
Results Reference
background
PubMed Identifier
1729621
Citation
Criqui MH, Langer RD, Fronek A, Feigelson HS, Klauber MR, McCann TJ, Browner D. Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med. 1992 Feb 6;326(6):381-6. doi: 10.1056/NEJM199202063260605.
Results Reference
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Etiology and Prevalence of Peripheral Arterial Disease
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