Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005142
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2000-05-25
Brief Title:
Etiology and Prevalence of Peripheral Arterial Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL022255 | NIH | None | httpsreporternihgovquickSearchR01HL022255 |