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Finding Acute Coronary Syndromes (ACS) With Serial Troponin Testing for Rapid Assessment of Cardiac Ischemic Symptoms

NCT00880802 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2010-01-12

No results posted yet for this study

Summary

Study Objectives

The following items will be prospectively assessed.

Primary Endpoints

1. For patients presenting with clinical suspicion of Acute Coronary Syndromes (ACS), high sensitivity-cardiac Troponin I (hs-cTnI) provides improved diagnostic accuracy for ACS (including Acute Myocardial Infarction (AMI) and/or Unstable Angina (UA)) within the first two (2) hours after emergency department presentation when compared to currently available troponin assays.
2. For patients presenting with clinical suspicion of ACS, hs-cTnI provides improved prognostic information with regard to 180 day event rates of Major Adverse Cardiac Event outcomes, including cardiac deaths which are defined as all deaths except those that are clearly non-cardiac in nature (e.g. trauma), when compared to a currently available troponin assay.

Secondary Endpoints

1. For patients presenting with clinical suspicion of ACS, using the rate of rise of hs-cTnI over time between presentation and 2 hours (delta hs-cTnI) allows for the differentiation between ACS and other disease states.
2. For patients presenting with clinical suspicion of ACS, hs-cTnI provides improved sensitivity for detecting AMI within the first two (2) hours after presentation when compared to a currently available troponin assay.
3. For patients presenting with clinical suspicion of ACS, hs-cTnI provides improved negative predictive value for ruling out ACS (AMI or UA) within the first 2 hours after presentation when compared to a currently available troponin assay.
4. For alternative endpoints of cardiac mortality, and for alternative censor time points of 30 days, 90 days, and 1 year, hs-cTnI provides improved prognostic information when compared to the currently available troponin assay.
5. In cases where the emergency physician has limited diagnostic confidence, hs-cTnI AMI diagnostic accuracy will be superior to local hospital standards for AMI determination.
6. In cases where the emergency physician has limited diagnostic confidence, the slope for the hs-cTnI between presentation and 2 hours will add diagnostic accuracy for ACS diagnosis over and above local hospital standards for ACS determination.
7. For patients presenting with clinical suspicion of ACS, the difference in diagnostic accuracy for ACS (including AMI and/or UA) using hs-cTnI measurement from time of onset of symptoms to emergency department presentation (e.g. 3 hours instead of 6 hours) will be evaluated to assess any variation.

Conditions

  • Acute Coronary Syndromes

Sponsors & Collaborators

  • Nanosphere, Inc.

    lead INDUSTRY

Principal Investigators

  • W. Frank Peacock, MD · The Cleveland Clinic

  • Christian Mueller, MD · University Hospital, Basel, Switzerland

  • Alan S Maisel, MD · Veterans Affairs Medical Center San Diego and University of California, San Diego

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-01-31
Completion
2011-03-31

Countries

  • United States
  • Greece
  • Italy
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00880802 on ClinicalTrials.gov