Point of Care (POC) Biomarkers of Ischemia
关键词
抽象
描述
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.
日期
最后验证: | 08/31/2019 |
首次提交: | 01/13/2014 |
提交的预估入学人数: | 01/15/2014 |
首次发布: | 01/19/2014 |
上次提交的更新: | 09/11/2019 |
最近更新发布: | 09/12/2019 |
实际学习开始日期: | 03/31/2013 |
预计主要完成日期: | 12/14/2014 |
预计完成日期: | 12/14/2014 |
状况或疾病
相
手臂组
臂 | 干预/治疗 |
---|---|
Controls/Normals control subjects without known cardiac disease, age ± 5 years and sex matched | |
Acute Coronary Syndrome requiring Percutaneous Intervention Subjects presenting to ER with Acute chest pain requiring cardiac catheterization | |
Acute Coronary Syndrome, no intervention Acute Coronary Syndrome, not requiring Percutaneous intervention |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
取样方式 | Non-Probability Sample |
接受健康志愿者 | 是 |
标准 | 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 |
结果
主要结果指标
1. Point of care Biomarkers of Ischemia Correlation [one year]
次要成果指标
1. Point of Care Biomarkers of Ischemia Comparison [one year]