Ignite Creation Date:
2024-05-06 @ 2:24 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02039882
Status:
COMPLETED
Last Update Posted:
2019-09-13
First Post:
2014-01-14
Brief Title:
Point of Care POC Biomarkers of Ischemia
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Point of Care POC Biomarkers of Ischemia
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute coronary syndrome is defined as myocardial infarction or ischemia as evidenced by significant coronary artery disease on cardiac catheterizationrevascularization 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 8of 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
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
Detailed Description:
Fifty patients presenting for evaluation of ACS acute coronary syndrome in the hospital emergency department ED will be studied and 50 control subjects without known cardiac disease that are age 5years and sex matched Pregnant women children and prisoners as well as individuals with hemoglobin less than 9 gdL will be excluded Blood will be drawn to analyze for the biomarkers inosine and hypoxanthine at the time standard of care biomarker troponin is sampled The levels of the biomarkers inosine and hypoxanthine will be measured by our research laboratory using LCmass spectrometryMS and luminescence methodologies Troponin levels will be measured as standard of care in the routine fashion by the hospital laboratory CLIA accredited at Virginia Commonwealth University Medical Center Demographic and clinical information will be obtained and the clinical course followed EKG data cardiac angiography and other cardiac assessment data eg ECHO rest and stress myocardial perfusion imaging that is performed as part of the standard of care evaluation will be collected and evaluated A maximum of 6 10 ml blood samples heparin anticoagulant for analysis will be drawn throughout the hospitalization
Twenty Five patients presenting 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
Twenty Five patients presenting with ACS requiring an immediate PCI Percutaneous Coronary Intervention will have blood samples drawn at time 0 immediately after intervention 1 3 and 6 hours Troponin samples will be acquired and analyzed as per routine practice time 0 3 6 hour and 2 additional troponin samples will be collected after reperfusion and 1 hour The analytical costs of these 2 samples will be charged to the department of Nephrology
Fifty age 5years and sex matched control subjects without known cardiac disease will have timed blood samples drawn at 0 3 and 6 hours These samples will be analyzed for troponin inosine and hypoxanthine
These patient samples will serve as the control group Control subjects will be recruited from the Virginia Commonwealth University Health Systems
Due to the acute nature of the patients presenting with chest pain a 10 ml sample of blood will be drawn at the time of the first routine blood draw for clinical purposes and the samples reserved until patient consent can be discussed If patient consents to participate the sample will be retained and added to other study samples If declined the sample will be discarded
Hypoxanthine and Inosine levels will be measured by LCMS mass spectrometry methods Luminescence technology used will be utilizing Lumistar Optima Microplate Reader Analysis of samples will be completed in batches throughout the study
Twenty Five patients presenting 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
Twenty Five patients presenting with ACS requiring an immediate PCI Percutaneous Coronary Intervention will have blood samples drawn at time 0 immediately after intervention 1 3 and 6 hours Troponin samples will be acquired and analyzed as per routine practice time 0 3 6 hour and 2 additional troponin samples will be collected after reperfusion and 1 hour The analytical costs of these 2 samples will be charged to the department of Nephrology
Fifty age 5years and sex matched control subjects without known cardiac disease will have timed blood samples drawn at 0 3 and 6 hours These samples will be analyzed for troponin inosine and hypoxanthine
These patient samples will serve as the control group Control subjects will be recruited from the Virginia Commonwealth University Health Systems
Due to the acute nature of the patients presenting with chest pain a 10 ml sample of blood will be drawn at the time of the first routine blood draw for clinical purposes and the samples reserved until patient consent can be discussed If patient consents to participate the sample will be retained and added to other study samples If declined the sample will be discarded
Hypoxanthine and Inosine levels will be measured by LCMS mass spectrometry methods Luminescence technology used will be utilizing Lumistar Optima Microplate Reader Analysis of samples will be completed in batches throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None