Point of Care (POC) Biomarkers of Ischemia
Completed
Conditions studied: Acute Coronary Syndrome, Myocardial Infarction
In brief
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 luminescence biomarker assessment will identify patients with ACS faster than traditional diagnostic methods. The goal of this study is to assess the role of rapid assessment of purine biomarkers in identifying patients who may have ACS.
Key facts
- Study ID
- NCT02039882
- Run by
- Virginia Commonwealth University
- People needed
- 85
- Starts
- 2013-04-01
- Expected to finish
- 2014-12-15
- Last updated by the study team
- 2019-09-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients presenting for evaluation of ACS (acute coronary syndrome) in the hospital emergency department (ED) control subjects without known cardiac disease that are age ± 5 years and sex matched to subjects with Acute coronary Syndrome
- Men and Women over age of 18
- Women who are not pregnant
- Subject who are not prisoners
- Hemoglobin greater than or equal to 9mg/dl
- Subjects who speak english
- Subjects 18 years of age or older
You may not qualify if…
- Men and Women under the age of 18 Women who are pregnant Subject who are prisoners Subjects who do not speak English Individuals with hemoglobin less than 9 g/dL Control subjects with known heart disease
Where it is running
- Virginia Commonwealtlh University Health Systems — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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