Point of Care (POC) Biomarkers of Ischemia

NCT02039882 | Completed

• 1 other identifier: HM15114
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Keywords

Acute Coronary Syndrome (ACS); Percutaneous Coronary Intervention PCI; Normals; Myocardial Infarction MI; Point of Care POC; Hypoxanthine; Inosine; HPLC High Pressure Liquid Chromatography

Outcome Measures

Primary Outcomes (1)

• Point of care Biomarkers of Ischemia Correlation

  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 Outcomes (1)

• Point of Care Biomarkers of Ischemia Comparison

  one year

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealtlh University Health Systems

Richmond, Virginia, 23298, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral blood, Plasma samples

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Todd Gehr, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 20, 2014
• Study Start: April 1, 2013
• Primary Completion: December 15, 2014
• Study Completion: December 15, 2014
• Last Updated: September 13, 2019

Record last verified: 2019-09

Locations

US (1)