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Usefulness of a 2-hour Delta Troponin-I During the ED Identification and Exclusion of Acute Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02002546
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Chattanooga-Hamilton County Hospital Authority

Brief Summary:
  1. In chest pain patients with suspected acute coronary syndrome, a 2-hr delta Troponin-I as measured by the i-STAT immunoassay reliably identifies and excludes an acute myocardial infarction.
  2. In chest pain patients with suspected acute coronary syndrome whose baseline troponin is above the 99th percentile but less than 0.2ng/ml, a 2hr delta Troponin-I as measured by the i-STAT immunoassay accurately discriminates between acute myocardial infarction and non-acute myocardial infarction troponin elevations.

Condition or disease
Acute Coronary Syndrome

Detailed Description:

Primary Aims: 1) Demonstrate that a 2hr delta troponin as measured by the i-STAT platform can reliably identify and exclude MI on the initial ED evaluation. 2)Demonstrate that a 2hr delta troponin is useful in the discrimination AMI versus non-AMI conditions in patients with low abnormal baseline Troponin-I values.

Secondary Aims: 1) Demonstrate that a positive 2-hr delta troponin-I identifies patients at highest risk for 30 day ACE. 2) Other Secondary aims TBD.

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Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Usefulness of a 2-hour Delta Troponin-I During the ED Identification and Exclusion of Acute Myocardial Infarction
Study Start Date : January 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : September 4, 2015

Resource links provided by the National Library of Medicine


Group/Cohort
ED chest pain presenting patients



Primary Outcome Measures :
  1. Change in Troponin value over a two hour interval. [ Time Frame: 2 hours after baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients presenting to the Emergency Department with chest pain or similar symptoms, and risk factors for ACS.
Criteria

Inclusion Criteria:

  1. Adult patients 18 years of age or older
  2. Chest pain suspicious for ACS
  3. Absence of ST-segment elevation AMI (STEMI) or STEMI equivalent on the initial ECG
  4. Baseline i-STAT troponin less or equal to 1.0 ng/ml
  5. Enrollment initiated before 2 hour 'delt' troponin value available for review
  6. Ability and willingness to participate and cooperate with telephone follow-up evaluations

Exclusion Criteria:

  1. ST-elevation or other ECG criteria that results in the diagnosis of AMI and results in patient being sent for percutaneous coronary interventions (PCI) or being treated with thrombolytics
  2. Patients with chest pain not deemed to warrant cardiac screening
  3. Blunt chest trauma
  4. Tachyarrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation)
  5. Cardiac Arrest prior to arrival
  6. Hemodynamically unstable patients
  7. Pulmonary edema requiring CPAP, BIPAP, or mechanical ventilation
  8. Baseline i-STAT troponin measurement greater than 1.0 ng/ml
  9. Baseline and 2-hour i-STAT Troponin measurements not obtained
  10. Patient (or Legal Representative) unable or unwilling to provide written informed consent
  11. Subject unwilling or unlikely to comply with study procedures, including protocol-specific blood sampling
  12. Subject unwilling, unable, or deemed unlikely to respond or participate in telephone follow-up
  13. Vulnerable populations as deemed inappropriate for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002546


Locations
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United States, Tennessee
Erlanger Baroness Medical Center
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
Chattanooga-Hamilton County Hospital Authority
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Responsible Party: Chattanooga-Hamilton County Hospital Authority
ClinicalTrials.gov Identifier: NCT02002546    
Other Study ID Numbers: IRB# 13-069
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Keywords provided by Chattanooga-Hamilton County Hospital Authority:
Heart Attack
Myocardial Infarction
Angina
Chest Pain
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases