Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217919
Status:
COMPLETED
Last Update Posted:
2014-04-09
First Post:
2005-09-19
Brief Title:
Reducing Risk Factors in Peripheral Arterial Disease
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Reducing Risk Factors in Peripheral Arterial Disease
Status:
COMPLETED
Status Verified Date:
2014-04
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:
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 peripheral arterial disease PAD
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 patients with PAD and coronary artery disease CAD While improved atherosclerotic risk factor treatment has reduced cardiovascular morbidity and mortality in patients with CAD such treatment in patients with PAD remains suboptimal Intensity of cholesterol-lowering therapy specifically is significantly poorer in patients with PAD as compared to CAD Data show that fully 69 percent of patients with PAD from a non-invasive vascular laboratory in Chicago did not have the recommended LDL-C level of less than 100 mgdl Our data from a national survey indicate that physicians believe atherosclerotic risk factor treatment is less important for patients with PAD than for patients with CAD Our data also show that many patients with PAD are unaware of their increased risk of cardiovascular events and under-appreciate the importance of risk factor treatment in PAD These findings likely contribute to risk factor under-treatment in patients with PAD Clinical trials such as this are needed to demonstrate whether PAD risk factors can be reduced If effective this clinical trial will also encourage clinicians to adopt the proven intervention to lower cardiovascular risks in patients with PAD
DESIGN NARRATIVE
This randomized controlled clinical trial will test the ability of a health-counselor mediated telephone counseling intervention as compared to usual care to reduce LDL-C levels in patients with PAD The study involves patients with PAD who have LDL-C levels greater than 100 mgdl at baseline identified from non-invasive vascular laboratories in Chicago IL and Worcester MA For their primary specific aim the investigators hypothesize that subjects randomized to the intervention condition will achieve a reduction in LDL-C of at least 111 mgdl greater than the reduction in LDL-C for subjects randomized to the usual care condition at 12-month follow-up In their secondary aim they will determine whether the telephone counseling intervention increases the proportion of PAD patients with LDL-C less than 100 mgdl as compared to the usual care condition at 12-month follow-up To identify the mediators of the intervention in their exploratory aims they will determine whether patients in the intervention condition achieve greater increases improvement in specific behavioral and knowledge and attitude mediators that will be targeted by the intervention as compared to patients in the usual care condition
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 patients with PAD and coronary artery disease CAD While improved atherosclerotic risk factor treatment has reduced cardiovascular morbidity and mortality in patients with CAD such treatment in patients with PAD remains suboptimal Intensity of cholesterol-lowering therapy specifically is significantly poorer in patients with PAD as compared to CAD Data show that fully 69 percent of patients with PAD from a non-invasive vascular laboratory in Chicago did not have the recommended LDL-C level of less than 100 mgdl Our data from a national survey indicate that physicians believe atherosclerotic risk factor treatment is less important for patients with PAD than for patients with CAD Our data also show that many patients with PAD are unaware of their increased risk of cardiovascular events and under-appreciate the importance of risk factor treatment in PAD These findings likely contribute to risk factor under-treatment in patients with PAD Clinical trials such as this are needed to demonstrate whether PAD risk factors can be reduced If effective this clinical trial will also encourage clinicians to adopt the proven intervention to lower cardiovascular risks in patients with PAD
DESIGN NARRATIVE
This randomized controlled clinical trial will test the ability of a health-counselor mediated telephone counseling intervention as compared to usual care to reduce LDL-C levels in patients with PAD The study involves patients with PAD who have LDL-C levels greater than 100 mgdl at baseline identified from non-invasive vascular laboratories in Chicago IL and Worcester MA For their primary specific aim the investigators hypothesize that subjects randomized to the intervention condition will achieve a reduction in LDL-C of at least 111 mgdl greater than the reduction in LDL-C for subjects randomized to the usual care condition at 12-month follow-up In their secondary aim they will determine whether the telephone counseling intervention increases the proportion of PAD patients with LDL-C less than 100 mgdl as compared to the usual care condition at 12-month follow-up To identify the mediators of the intervention in their exploratory aims they will determine whether patients in the intervention condition achieve greater increases improvement in specific behavioral and knowledge and attitude mediators that will be targeted by the intervention as compared to patients in the usual care condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL073912 | NIH | None | httpsreporternihgovquickSearchR01HL073912 |