Point of Care (POC) Biomarkers of Ischemia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/13/2018 |
| Start Date: | April 2013 |
| End Date: | August 2019 |
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.
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.
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 g/dL 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 LC/mass spectrometry(MS) 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 (e.g. 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 LC/MS (mass spectrometry) methods.
Luminescence technology used will be utilizing Lumistar Optima Microplate Reader. Analysis of
samples will be completed in batches throughout the study.
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 g/dL 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 LC/mass spectrometry(MS) 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 (e.g. 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 LC/MS (mass spectrometry) methods.
Luminescence technology used will be utilizing Lumistar Optima Microplate Reader. Analysis of
samples will be completed in batches throughout the study.
Inclusion Criteria:
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
Exclusion Criteria:
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
We found this trial at
1
site
Richmond, Virginia 23298
Principal Investigator: Todd Gehr, MD
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