Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 52 of 648 for:    test AND point-of-care

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

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: 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

Tracking Information
First Submitted Date September 14, 2005
First Posted Date September 22, 2005
Last Update Posted Date February 5, 2018
Actual Study Start Date December 2004
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2018)
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00222352 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 1, 2018)
Time to departure [ Time Frame: time of discharge to home or to the time of transfer to an inpatient setting ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnosis and Treatment of ACS in the ED: The Impact of Rapid Bedside cTnI Testing on Outcomes
Official Title Diagnosis and Treatment of Acute Coronary Syndromes in the Emergency Department: The Impact of Rapid Bedside cTnI Testing on Outcomes
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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.
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.
Condition Angina, Unstable
Intervention 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.

Study Groups/Cohorts
  • central laboratory cTnI test
    Control Group
  • Point of Care cTnL testing
    Experimental Group
    Intervention: Diagnostic Test: Point of Care cTnL testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 14, 2005)
2000
Original Enrollment Same as current
Actual Study Completion Date March 2007
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00222352
Other Study ID Numbers TJH 04-28
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Blood samples banked for future use. Must be IRB approved before use.
Responsible Party Brian Gibler, University of Cincinnati
Study Sponsor University of Cincinnati
Collaborators
  • Abbott
  • Jewish Hospital, Cincinnati, Ohio
  • University of Pennsylvania
  • Stanford University
  • Mayo Clinic
Investigators
Study Chair: Walter B Gibler, MD University of Cincinnati
PRS Account University of Cincinnati
Verification Date February 2018