Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00046592
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2002-09-30
Brief Title:
Mechanisms of Disability in 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:
2008-01
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 mechanisms by which atherosclerotic peripheral artery disease PAD causes functional impairment and to define the degree to which peripheral artery disease associated pathophysiologic findings change over time
Detailed Description:
BACKGROUND
Research demonstrates that men and women with lower extremity peripheral arterial disease PAD have poorer functioning than men and women without PAD Preliminary data also indicate that more severe PAD at baseline as measured by the ankle brachial index ABI is associated with a greater incidence of functional loss However the pathophysiologic mechanisms in the lower extremities responsible for PAD-related functional impairment and functional loss are not well defined
DESIGN NARRATIVE
The study cohort will consist of 790 individuals identified from three Chicago-area medical centers of whom 500 will have PAD Participants will undergo a baseline and two annual follow-up visits Pathophysiologic findings in the lower extremities refer to reduced muscle mass reduced muscle quality and reduced peripheral sensory and motor function Quality of muscle tissue is defined as the ratio of muscle force to muscle mass Muscle mass will be measured with Computed Tomography CT Peripheral nerve function will be determined using surface electroneurography ENG Lower extremity functional measures will consist of measures pertinent to functioning during daily living and include six minute walk distance seven-day physical activity level assessed by accelerometer walking speed balance tests and lower extremity muscle power
The cross-sectional study will test the hypotheses that a chronic lower extremity arterial ischemia is associated with specific pathophysiologic findings in lower extremity muscle and nerve and that b these ischemia-related pathophysiologic findings are associated with lower extremity functional limitationThe longitudinal study will test the hypotheses that a greater baseline lower extremity arterial ischemia as measured by ABI is associated with greater progression of pathophysiologic findings over two year follow-up and that b greater ischemia-related pathophysiologic findings in the legs at baseline is associated with greater functional decline over two year follow up Results will be used to develop interventions designed to improve lower extremity functioning and prevent functional decline in persons with PAD
Research demonstrates that men and women with lower extremity peripheral arterial disease PAD have poorer functioning than men and women without PAD Preliminary data also indicate that more severe PAD at baseline as measured by the ankle brachial index ABI is associated with a greater incidence of functional loss However the pathophysiologic mechanisms in the lower extremities responsible for PAD-related functional impairment and functional loss are not well defined
DESIGN NARRATIVE
The study cohort will consist of 790 individuals identified from three Chicago-area medical centers of whom 500 will have PAD Participants will undergo a baseline and two annual follow-up visits Pathophysiologic findings in the lower extremities refer to reduced muscle mass reduced muscle quality and reduced peripheral sensory and motor function Quality of muscle tissue is defined as the ratio of muscle force to muscle mass Muscle mass will be measured with Computed Tomography CT Peripheral nerve function will be determined using surface electroneurography ENG Lower extremity functional measures will consist of measures pertinent to functioning during daily living and include six minute walk distance seven-day physical activity level assessed by accelerometer walking speed balance tests and lower extremity muscle power
The cross-sectional study will test the hypotheses that a chronic lower extremity arterial ischemia is associated with specific pathophysiologic findings in lower extremity muscle and nerve and that b these ischemia-related pathophysiologic findings are associated with lower extremity functional limitationThe longitudinal study will test the hypotheses that a greater baseline lower extremity arterial ischemia as measured by ABI is associated with greater progression of pathophysiologic findings over two year follow-up and that b greater ischemia-related pathophysiologic findings in the legs at baseline is associated with greater functional decline over two year follow up Results will be used to develop interventions designed to improve lower extremity functioning and prevent functional decline in persons with PAD
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 |
|---|---|---|---|
| R01HL071223 | NIH | None | httpsreporternihgovquickSearchR01HL071223 |