Status:
COMPLETED
BRAVO: Biomarker Risk Assessment in Vulnerable Outpatients
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
Brief Summary
The investigators hypothesize that among people with lower extremity peripheral artery disease (PAD), biomarker levels are higher during time periods immediately preceding an acute coronary event comp...
Eligibility Criteria
Inclusion
- Peripheral arterial disease defined as an ABI less than or equal to 0.90 in either leg
- We will also include PAD patients with an ABI \> 0.90 who meet any of the following criteria:
- History of documented lower extremity revascularization. A written report from the medical record will be required as documentation
- An angiogram demonstrating \>50% stenosis in one or more lower extremity arteries. Again, a written report will be required to document this. Participants with an angiogram noting moderate or greater stenosis will also be considered eligible, when a specific amount of stenosis is not denoted
- A report from the non-invasive vascular laboratory demonstrating a toe brachial pressure less than 0.60. Other criteria (i.e. PVR data) from the non-invasive vascular laboratory will not be considered sufficient for inclusion
Exclusion
- Treatment for cancer other than non-melanoma skin cancer during the previous 2 years. (However, persons treated for non-invasive breast cancer or prostate cancer during the previous year will be potentially eligible if their physician indicates that their life expectancy is \> 24 months, since non-invasive breast and prostate cancer often have an excellent prognosis)
- Unintentional weight loss of \> 7.5 pounds in the last six months;
- Mini-Mental Status Exam (MMSE) score \< 23 out of 30 or other history of cognitive impairment
- Communication difficulty due to language barriers
- Refusal to have regular blood draws or inability to obtain a blood sample at baseline
- Coronary or cerebrovascular event during the previous six months (these persons may become eligible at a later date)
- History of inflammatory arthritis (rheumatoid arthritis, lupus erythematosis, or polymyalgia rheumatic, gout), however participants with gouty arthritis will be eligible if the last episode was more than three months ago
- Residence more than 40 miles away from the medical center and unwillingness to travel to the medical center for every two month blood collection
- Unable to return for follow up testing for \> a consecutive six month period in the next two years
- Heart transplant surgery
- Major surgery (one that required general anesthesia) within the past 3 months These persons may become eligible at a later date
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
595 Patients enrolled
Trial Details
Trial ID
NCT02276781
Start Date
September 1 2009
End Date
January 1 2013
Last Update
May 6 2015
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Mt. Sinai Medical Center
Chicago, Illinois, United States, 60608
2
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
3
Jesse Brown Veterans Administration Medical Center
Chicago, Illinois, United States, 60612
4
Rush Medical Center
Chicago, Illinois, United States, 60612