Peripheral Arterial DiseaseBRAVONCT02276781
BRAVO: Biomarker Risk Assessment in Vulnerable Outpatients
An observational study of Peripheral Arterial Disease, run by Northwestern University at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 595 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2009to Jan 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Mt. Sinai Medical Center
Chicago, Illinois, 60608
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Jesse Brown Veterans Administration Medical Center
Chicago, Illinois, 60612
Rush Medical Center
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
St. Joseph's Hospital
Chicago, Illinois, 60657
About this study
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.
- Conditions
- Peripheral Arterial Disease
- Keywords
- PAD, Peripheral Arterial Disease, Biomarkers
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PAD Participants | PAD participants from among consecutive patients with PAD identified from Chicago area non-invasive vascular laboratories |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatal and non-fatal coronary events
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
Measured: Every two months for up to three and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startSep 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 595 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Mary McDermott, Northwestern University
- Investigators
- Mary M McDermott, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276781
- Sponsor's protocol ID
- R01HL089619
- Other IDs
- R01HL089619
- Acronym
- BRAVO
- Status last verified
- May 2015
- First submitted
- 24 Oct 2014
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRAVO: Biomarker Risk Assessment in Vulnerable Outpatients
- ClinicalTrials.gov ID
- NCT02276781
- Acronym / sponsor ID
- BRAVO / R01HL089619
- Conditions
- Peripheral Arterial Disease
- Keywords
- PAD, Peripheral Arterial Disease, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 595 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Oct 2014 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAD Participants | – | –PAD participants from among consecutive patients with PAD identified from Chicago area non-invasive vascular laboratories |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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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.
Mary M McDermott, MD principal investigator
Northwestern University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Northwestern University at 6 sites 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 5 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: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
fatal and non-fatal coronary events (time frame: Every two months for up to three and a half years). It is what the study was designed to measure, not a finding.
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 6 May 2015.