Peripheral Vascular DiseaseNCT00274157
FIRE-PAD: Functional Improvement Through Revascularization of the Extremities for Peripheral Arterial Disease
An observational study of Peripheral Vascular Disease, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Behavior
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- • Vascular anatomy inappropriate for a catheter-based procedure on the basis of non-invasive studies
- Critical limb ischemia (rest pain, non-healing ulcer, gangrene)
- Contraindication to contrast arteriography
- Vascular surgery or prior catheter-based vascular intervention within the preceding 6 months
- Patients with suspected or confirmed graft stenoses or occlusions
- Myocardial infarction or hospitalization for unstable angina, coronary artery bypass grafting or percutaneous coronary intervention, within the preceding one month
Show all 11Show fewer
- Stroke or transient ischemic attack within the preceding one month
- Pregnancy or planned pregnancy during the one year of participation in the trial.
- Any active chronic inflammatory condition,including autoimmune disorder or active malignancy.Subjects unable to walk, amputees, and subjects with a contraindication to treadmill exercise.
- Patients with dementia or other significant cognitive impairment
- Patients who are non-English speaking, (due to the need for subjects to complete standardized questionnaires)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Behavior, diet control, smoking cessation, exercize
- Keywords
- Peripheral Vascular Disease, Intermittent Claudication, Catheter-based Arterial Revascularization, Peripheral angioplasty, Peripheral stenting, Functional capacity, Quality of life
- Medical subject headings
- Peripheral Vascular Diseases, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehaviorBehavioural
diet control, smoking cessation, exercizeBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startMar 2007
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Heather L Gornik, M.D. M.H.S., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274157
- Sponsor's protocol ID
- FIRE-PAD
- Status last verified
- Jun 2008
- First submitted
- 9 Jan 2006
- Last updated
- 27 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00274157
- Acronym / sponsor ID
- FIRE-PAD
- Conditions
- Peripheral Vascular Disease
- Keywords
- Peripheral Vascular Disease, Intermittent Claudication, Catheter-based Arterial Revascularization, Peripheral angioplasty, Peripheral stenting, Functional capacity, Quality of life
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 10 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- • Vascular anatomy inappropriate for a catheter-based procedure on the basis of non-invasive studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavior | Behavioural | – |
| diet control, smoking cessation, exercize | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather L Gornik, M.D. M.H.S. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Disease, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2008.