Natural History of Peripheral Arterial Disease
Primary Purpose
Atherosclerosis, Coronary Disease, Arterial Occlusive Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Atherosclerosis
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005254
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
NCT00005254
Brief Title
Natural History of Peripheral Arterial Disease
Study Type
Observational
2. Study Status
Record Verification Date
June 2000
Overall Recruitment Status
Completed
Study Start Date
April 1990 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 1995 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
The Veterans Administration Patient Study examined the progression of peripheral arterial disease (PAD) in patients with large vessel PAD or isolated small vessel PAD. The Community Follow-up Study following subjects with and without PAD from a previous cohort to determine subsequent coronary heart disease and cardiovascular disease morbidity and mortality.
Detailed Description
BACKGROUND:
Peripheral arterial disease is a common condition, particularly in the elderly, but is the least frequently studied and the least well understood of the major atherosclerotic diseases.
DESIGN NARRATIVE:
Veterans Administration Patient Study: The progression of PAD was followed in patients diagnosed at the San Diego VA Medical Center from July 1984 to June 1989. Four non-invasive tests used in the initial diagnosis were repeated after a five year interval. The tests included segmental blood pressure flow velocity by Doppler ultrasound, post-occlusive reactive hyperemia, and pulse reappearance time. Risk factors examined for related to PAD included cigarette smoking, alcohol consumption, lipids and lipoproteins, blood pressure, fasting plasma glucose, diabetes history, immunoglobulin E, and creatinine. The degree of concordance between PAD and carotid disease was evaluated using phonoangiography.
Community Follow-up Study: The study was conducted in a cohort first examined for PAD in 1978-1981 and followed for morbidity and mortality.
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
Atherosclerosis, Coronary Disease, Arterial Occlusive Diseases, Peripheral Vascular Diseases, Cardiovascular 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
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
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
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PubMed Identifier
8067346
Citation
Feigelson HS, Criqui MH, Fronek A, Langer RD, Molgaard CA. Screening for peripheral arterial disease: the sensitivity, specificity, and predictive value of noninvasive tests in a defined population. Am J Epidemiol. 1994 Sep 15;140(6):526-34. doi: 10.1093/oxfordjournals.aje.a117279.
Results Reference
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PubMed Identifier
10512592
Citation
Long TH, Criqui MH, Vasilevskis EE, Denenberg JO, Klauber MR, Fronek A. The correlation between the severity of peripheral arterial disease and carotid occlusive disease. Vasc Med. 1999;4(3):135-42. doi: 10.1177/1358836X9900400303.
Results Reference
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PubMed Identifier
10355865
Citation
Bird CE, Criqui MH, Fronek A, Denenberg JO, Klauber MR, Langer RD. Quantitative and qualitative progression of peripheral arterial disease by non-invasive testing. Vasc Med. 1999;4(1):15-21. doi: 10.1177/1358836X9900400103.
Results Reference
background
PubMed Identifier
9546918
Citation
Criqui MH, Denenberg JO, Bird CE, Fronek A, Klauber MR, Langer RD. The correlation between symptoms and non-invasive test results in patients referred for peripheral arterial disease testing. Vasc Med. 1996;1(1):65-71. doi: 10.1177/1358863X9600100112.
Results Reference
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Natural History of Peripheral Arterial Disease
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