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

Study Description

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.

Condition or disease
Peripheral Arterial Disease

Study Design

• Study Type: Observational
• Actual Enrollment: 595 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: BRAVO: Biomarker Risk Assessment in Vulnerable Outpatients
• Study Start Date: September 2009
• Actual Primary Completion Date: January 2013
• Actual Study Completion Date: January 2013

Groups and Cohorts

Group/Cohort
PAD Participants; PAD participants from among consecutive patients with PAD identified from Chicago area non-invasive vascular laboratories

Outcome Measures

Primary Outcome Measures :

1. 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

Biospecimen Retention:   Samples With DNA

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

*genetic factors and muscle biopsies are optional study elements

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

United States, Illinois

Mt. Sinai Medical Center

Chicago, Illinois, United States, 60608

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States, 60611

Jesse Brown Veterans Administration Medical Center

Chicago, Illinois, United States, 60612

Rush Medical Center

Chicago, Illinois, United States, 60612

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

St. Joseph's Hospital

Chicago, Illinois, United States, 60657

Sponsors and Collaborators

Northwestern University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

More Information

• Responsible Party: Mary McDermott, Professor of Medicine, Northwestern University
• ClinicalTrials.gov Identifier: NCT02276781
• Other Study ID Numbers: R01HL089619 ( U.S. NIH Grant/Contract ); R01HL089619 ( U.S. NIH Grant/Contract )
• First Posted: October 28, 2014
• Last Update Posted: May 6, 2015
• Last Verified: May 2015

Keywords provided by Mary McDermott, Northwestern University:

PAD; Peripheral Arterial Disease; Biomarkers

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases