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NCT02276781 · ClinicalTrials.gov registry record
BRAVO: Biomarker Risk Assessment in Vulnerable Outpatients
A clinical trial of Peripheral Arterial Disease, sponsored by Northwestern University.
- Completed
- Registry status
- 595
- Enrollment target
- 6
- Study locations
NCT02276781: Completed study of Peripheral Arterial Disease, sponsored by Northwestern University.
NCT02276781 is a study of Peripheral Arterial Disease that has completed, run by Northwestern University. The registered enrollment target is 595 participants, below the 4,199-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (86% lower). The trial reports 6 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02276781, a study of Peripheral Arterial Disease, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 595 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Study Locations (6)
Illinois
- Mt. Sinai Medical Center - Chicago
- Northwestern University Feinberg School of Medicine - Chicago
- Jesse Brown Veterans Administration Medical Center - Chicago
- Rush Medical Center - Chicago
- University of Chicago Medical Center - Chicago
- St. Joseph's Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 595 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-01 |
What the finished NCT02276781 record still lists
NCT02276781 is an observational study that tracks outcomes without assigning an intervention. The registered 595 participants enrollment target is mid-sized for trials with a published cap, below the 4,199-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 0 interventions.
NCT02276781 lists 6 locations in 1 state (Illinois).
Frequently Asked Questions
What is clinical trial NCT02276781 about?
NCT02276781 is a clinical study titled "BRAVO: Biomarker Risk Assessment in Vulnerable Outpatients". 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...
What is the current status of trial NCT02276781?
This trial is currently completed. The enrollment target is 595 participants. The study started on 2009-09. Estimated completion is 2013-01.
What conditions does trial NCT02276781 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease.
Who is sponsoring clinical trial NCT02276781?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02276781 being conducted?
This trial has 6 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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participants (enrollment target), bucketed by value
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