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NCT02039882 · ClinicalTrials.gov registry record
Point of Care (POC) Biomarkers of Ischemia
A clinical trial, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- 85
- Enrollment target
NCT02039882: Completed study, sponsored by Virginia Commonwealth University.
NCT02039882 is a clinical trial that has completed, run by Virginia Commonwealth University. The registered enrollment target is 85 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02039882 has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- 85 participants
- Enrollment target
Study Summary
Acute coronary syndrome is defined as myocardial infarction or ischemia as evidenced by significant coronary artery disease on cardiac catheterization/revascularization or reversible defect seen on stress test. Each year approximately 8-10 million patients undergo an emergency department evaluation for possible acute coronary syndrome (ACS) in the United States Up to 8%of patients who have myocardial infarction (MI) are inadvertently discharged. Unnecessary admissions for presumed myocardial disease result in health care costs that are estimated to exceed 5 billion dollars annually Currently, the cardiac biomarkers troponin and Creatine phosphokinase (CPK-MB), in conjunction with ECG changes are used to evaluate a patient routinely for ACS. However, these tests have limitations for identifying most patients who have ACS in a rapid fashion. Purine molecules such as inosine and hypoxanthine and have been shown to also be biomarkers of acute MI. High pressure liquid chromatography (HPLC) is the traditional method of analysis of these purines. The HPLC method however requires hours to assess biomarkers, as do the more traditionally used troponin and CK-MB methods. Recently, the investigator has developed a rapid chemo luminescence method for detecting purine biomarkers. This modality can provide an expeditious (requires less than 4 minutes to complete analysis), bedside method of analysis for ACS through routinely acquired blood samples. In this study the investigator will compare the results of the chemo luminescence method with the gold standard HPLC method, and results of the traditional cardiac markers troponin and Creatine phosphokinase (CK-MB) in patients undergoing an evaluation for ACS. Details of noninvasive and invasive cardiac assessments performed as part of the routine evaluation by the clinician for myocardial assessment and intervention in conjunction with biomarker assessment will be obtained. The investigator hypothesize that the rapid chemo luminescen
Primary Outcome
correlation of biomarkers of inosine and hypoxanthine measurements using rapid chemoluminescence method with HPLC quantitation. Subjects with ACS not requiring an immediate (PCI) Percutaneous Coronary Intervention: will have samples drawn at 0, 3 and 6 hours after vascular access has been acquired. Blood samples for analysis as standard of care for troponin are at 0, 3 and 6 hours. ACS requiring an immediate PCI Percutaneous Coronary Intervention will have blood samples drawn at time 0, immediat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-12-15 |
What the finished NCT02039882 record still lists
NCT02039882 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 85 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02039882 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02039882 about?
NCT02039882 is a clinical study titled "Point of Care (POC) Biomarkers of Ischemia". Acute coronary syndrome is defined as myocardial infarction or ischemia as evidenced by significant coronary artery disease on cardiac catheterization/revascularization or reversible defect seen on stress test. Each year approximately 8-10 million patients undergo an emergency department evaluation ...
What is the current status of trial NCT02039882?
This trial is currently completed. The enrollment target is 85 participants. The study started on 2013-04. Estimated completion is 2014-12-15.
Who is sponsoring clinical trial NCT02039882?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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