Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-31 @ 5:07 AM
Study NCT ID:
NCT00274157
Status:
TERMINATED
Last Update Posted:
2008-06-27
First Post:
2006-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FIRE-PAD: Functional Improvement Through Revascularization of the Extremities for Peripheral Arterial Disease
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
Functional Improvement Through Revascularization of the Extremities for Peripheral Arterial Disease (FIRE-PAD). Effects of Catheter-Based Revascularization on Functional Capacity, Quality of Life, and the Cardiovascular Risk Profile of Patients With Intermittent Claudication
Status:
TERMINATED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The specific aims of the project are as follows:
To determine whether catheter-based revascularization procedures improve functional capacity and quality of life among patients with intermittent claudication.
To investigate whether improvements in walking ability result in a less sedentary lifestyle and improvement of the cardiovascular risk profile.
To determine whether catheter-based revascularization procedures improve functional capacity and quality of life among patients with intermittent claudication.
To investigate whether improvements in walking ability result in a less sedentary lifestyle and improvement of the cardiovascular risk profile.
Detailed Description:
Patients with intermittent claudication have decreased functional abilities and impaired quality of life \[QOL\]. In addition, peripheral arterial disease is associated with an increased risk of a life threatening cardiovascular event. Due to advances in endovascular technologies, peripheral revascularization procedures are now offered to a growing number of patients with lifestyle limiting claudication, rather than solely for the treatment of critical limb ischemia. Indeed, according to data derived from the National Health Discharge Survey, there was a 979% increase in the number of catheter-based revascularization procedures performed during the period 1995-2000. Despite well defined patency outcomes, the functional and QOL benefits of catheter-based revascularization procedures are largely undefined. In addition to improving leg symptoms and QOL, increasing walking ability among patients with claudication may lead to a less sedentary lifestyle and improvement of the cardiovascular risk factor profile. However, this relationship has not yet been demonstrated. The proposed project is a longitudinal cohort study that will follow patients with intermittent claudication for one year after a catheter-based revascularization procedure to measure changes in functional capacity, QOL, and cardiovascular risk factors. Patients will be evaluated at baseline and at 3 and 12 months following the procedure. A total of 60 patients will be studied over a three-year period. Functional parameters to be assessed will include treadmill walking distances, the 6-minute walk test, walking velocity, and self-assessed walking ability as determined by the Walking Impairment Questionnaire. Activity level during daily life will be assessed using a vertical accelerometer device, which will be worn by patients for a 7-day period at each time point. Quality of life will be assessed by the Short Form-36 Questionnaire and the Geriatric Depression Scale. Cardiovascular risk factors to be measured will include anthropomorphic parameters, blood pressure, lipids, markers of inflammation, homocysteine, and insulin-sensitivity. It is intended that data generated from this study will provide initial data to plan a multi-centered randomized clinical trial of best medical therapy and exercise training versus catheter-based revascularization for the treatment of lifestyle limiting claudication.
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?: