BRAVO: Biomarker Risk Assessment in Vulnerable Outpatients (BRAVO)

• ClinicalTrials.gov Identifier: NCT02276781
• Recruitment Status: Completed
• First Posted: October 28, 2014
• Last Update Posted: May 6, 2015
• Sponsor: Northwestern University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Mary McDermott, Northwestern University

Tracking Information

• First Submitted Date: October 24, 2014
• First Posted Date: October 28, 2014
• Last Update Posted Date: May 6, 2015
• Study Start Date: September 2009
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 27, 2014)

fatal and non-fatal coronary events [ Time Frame: Every two months for up to three and a half years ]

Our primary outcome is fatal and non-fatal coronary events. Non-fatal coronary events will be defined as acute myocardial infarction (MI), hospitalizations for unstable angina, and new ECG findings consistent with MI

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: BRAVO: Biomarker Risk Assessment in Vulnerable Outpatients
• Official Title: BRAVO: Biomarker Risk Assessment in Vulnerable Outpatients

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 compared to time periods not immediately preceding an acute coronary event. Biomarkers the investigators will study are CRP, SAA, and D-dimer. Biomarkers will be measured at baseline and every two months during follow-up.

The primary aims of this study are as follows. Specific Aim #1. Among participants with PAD who experience an acute coronary event during follow-up, the investigators will determine whether biomarker levels measured immediately prior to the coronary event are higher than levels that do not immediately precede coronary events. Specific Aim #2, Part 1. The investigators will determine whether participants who experience a coronary event (cases) have higher biomarker levels at the visit immediately prior to the event than participants who have not experienced a coronary event (controls) at the time of the case event. Specific Aim #2, Part 2. The investigators will determine whether participants who experience a coronary event (cases) have a greater increase in biomarkers during the time period leading up to the event compared to participants who have not experienced a coronary event (controls).

To achieve these aims, the investigators will enroll up to 650 participants with PAD and follow them prospectively, measuring blood samples every two months, and ascertaining the presence of acute coronary events every two months.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Blood: EDTA plasma, Citrate plasma, serum, whole blood (DNA)* and RNA*. Lower extremity muscle biopsies*

*genetic factors and muscle biopsies are optional study elements

• Sampling Method: Non-Probability Sample
• Study Population: PAD participants from among consecutive patients with PAD identified from Chicago area non-invasive vascular laboratories and vascular surgery, cardiology, general internal medicine, geriatric, and endocrinology clinics.
• Condition: Peripheral Arterial Disease
• Intervention: Not Provided

Study Groups/Cohorts

PAD Participants

PAD participants from among consecutive patients with PAD identified from Chicago area non-invasive vascular laboratories

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 27, 2014): 595
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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 Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02276781
• Other Study ID Numbers: R01HL089619( U.S. NIH Grant/Contract ); R01HL089619 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mary McDermott, Northwestern University
• Study Sponsor: Northwestern University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Mary M McDermott, MD; Northwestern University

• PRS Account: Northwestern University
• Verification Date: May 2015