Point of Care (POC) Biomarkers of Ischemia

September 12, 2019 updated by: Virginia Commonwealth University

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.

Study Overview

Status

Completed

Conditions

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 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.

Study Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealtlh University Health Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Fifty total patients presenting for evaluation of ACS (acute coronary syndrome) in the hospital emergency department (ED) at Virginia Commonwealth University Health Systems, Twenty five Patents requiring percutaneous Intervention, Twenty five patients not requiring intervention Fifty control subject from Virginia Commonwealth University Health Systems without known cardiac disease that are age ± 5years and sex matched from

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Point of care Biomarkers of Ischemia Correlation
Time Frame: one year
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, 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).
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Point of Care Biomarkers of Ischemia Comparison
Time Frame: one year
Investigator will compare measurements of inosine and hypoxanthine with traditional markers of MI, 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, 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).
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Todd Gehr, MD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 15, 2014

Study Completion (Actual)

December 15, 2014

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Actual)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 12, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM15114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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