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Diagnosis and Treatment of ACS in the ED: The Impact of Rapid Bedside cTnI Testing on Outcomes (Dispo-ACS)

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ClinicalTrials.gov Identifier: NCT00222352
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 5, 2018
Sponsor:
Collaborators:
Abbott
Jewish Hospital, Cincinnati, Ohio
University of Pennsylvania
Stanford University
Mayo Clinic
Information provided by (Responsible Party):
Brian Gibler, University of Cincinnati

Brief Summary:
In a randomized, controlled clinical trial, point-of care testing at the bedside using the cardiac biomarker troponin I in ED patients with possible ACS will be compared to traditional testing of this assay for myocardial necrosis obtained in the central laboratory. Our hypothesis: point-of-care testing for troponin I will decrease the time for disposition of patients with possible ACS in the emergency setting and decrease the time required for administering appropriate therapies for these patients.

Condition or disease Intervention/treatment
Angina, Unstable Diagnostic Test: Point of Care cTnL testing

Detailed Description:
Cardiac troponin I is routinely used in the emergency department as a risk stratification tool for detecting myocardial necrosis in patients with possible acute coronary syndrome. It is our hypothesis that having bedside, point-of-care testing for TnI in the ED will decrease time needed to disposition patients to home from the ED or send to the cardiac catheterization laboratory or intensive care setting. Similarly, having point-of-care testing in the ED should decrease the time required to deliver anti-platelet drugs such as aspirin and glycoprotein IIb/IIIa inhibitors and anti-thrombin agents such as heparin to high risk patients found to have a positive TnI test. This will be evaluated in a randomized, controlled clinical trial of 2000 patients. Half will have the test performed in the ED at the bedside (point-of-care) while the other half will receive the usual lab results obtained from the central lab (typically requiring 1.5-2 hours to return).

Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnosis and Treatment of Acute Coronary Syndromes in the Emergency Department: The Impact of Rapid Bedside cTnI Testing on Outcomes
Actual Study Start Date : December 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : March 2007

Group/Cohort Intervention/treatment
central laboratory cTnI test
Control Group
Point of Care cTnL testing
Experimental Group
Diagnostic Test: Point of Care cTnL testing

The study design will be a phase IV prospective, randomized (1:1), parallel-group trial utilizing concurrent controls. The experimental group of interest will be patients receiving the POC cTnI test, and the control group will be patients receiving the central laboratory cTnI test.

The treating physician will be blinded to the randomization and will receive only the POC results from half the study patients and only the laboratory results for the remaining half.




Primary Outcome Measures :
  1. Time to disposition from the ED [ Time Frame: The time from blood draw to initiation of therapy or to disposition ]
    The primary hypotheses are that i) POC testing using the i-STAT system reduces the time to disposition and discharge for low-risk patients being discharged directly from the ED, and ii) POC testing using the i-STAT system reduces the time to therapy compared to laboratory testing for the subset of patients requiring anti-thrombotic therapies such as heparin/LMW heparin or anti-platelet agents such as GPIIb/IIIa inhibitors or clopidogrel or PCI. These groups of patients (those with new ST-depression, recurrent pain, positive troponin, diabetes, age >65 years, or failed ASA and those discharged without a diagnosis associated with ischemic chest pain) will be extracted from the entire sample. The time from blood draw to initiation of therapy or to disposition and discharge will be computed and compared between the group with POC testing and the group with laboratory testing.


Secondary Outcome Measures :
  1. Time to departure [ Time Frame: time of discharge to home or to the time of transfer to an inpatient setting ]

Biospecimen Retention:   Samples Without DNA
SERUM BANKING Each patient consented and enrolled will have whole blood and plasma saved and frozen. The amount of blood drawn for the study is 5 ml (per draw), which is to be placed in a lithium heparinzed tube. One ml of whole blood will be alloquoted, frozen at -70ºC, and shipped to the Study Coordinating Center. The remainder of the sample will be centrifuged, alloquoted, frozen at -70ºC, and shipped to the Study Coordinating Center. These blood samples will be de-identified and assigned a study ID #. There will be no genetic testing of these samples.


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 21 years or older, presenting with symptoms suggestive of acute coronary syndromes, and having cardiac biomarker tests ordered by the treating emergency physician were enrolled. Patients with a tachydysrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation) or a 12-lead ECG diagnostic for acute myocardial infarction were excluded. Patients were enrolled at 4 sites across the United States between December 2004 and November 2006, with final data collection and verification occurring by March 2007.
Criteria

Inclusion criteria

  • Age >21 years old
  • Chest pain or other symptoms that lead to drawing cardiac bio-markers for possible ACS diagnosis

Exclusion criteria

  • Presentation with chest pain in the presence of a tachydysrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation)
  • Presentation with ECG diagnostic for STEMI

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): NCT00222352


Locations
United States, California
Stanford University
Stanford, California, United States, 94305-6203
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Ohio
The Jewish Hospital
Cincinnati, Ohio, United States, 45236
United States, Pennsylvania
The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6205
Sponsors and Collaborators
University of Cincinnati
Abbott
Jewish Hospital, Cincinnati, Ohio
University of Pennsylvania
Stanford University
Mayo Clinic
Investigators
Study Chair: Walter B Gibler, MD University of Cincinnati

Responsible Party: Brian Gibler, Study Chairman, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00222352     History of Changes
Other Study ID Numbers: TJH 04-28
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Blood samples banked for future use. Must be IRB approved before use.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brian Gibler, University of Cincinnati:
Unstable Angina
Non-ST-segment Myocardial Infarction
Myocardial Necrosis
Troponin I

Additional relevant MeSH terms:
Angina, Unstable
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms