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

NCT00222352 | Completed

• 1 other identifier: TJH 04-28
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 4

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.

Conditions

Angina, Unstable

Keywords

Unstable Angina; Non-ST-segment Myocardial Infarction; Myocardial Necrosis; Troponin I

Outcome Measures

Primary Outcomes (1)

• Time to disposition from the ED

  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.

  The time from blood draw to initiation of therapy or to disposition

Secondary Outcomes (1)

• Time to departure

  time of discharge to home or to the time of transfer to an inpatient setting

Study Arms (2)

central laboratory cTnI test

Control Group

Point of Care cTnL testing

Experimental Group

Diagnostic Test: Point of Care cTnL testing

Interventions

Point of Care cTnL testing DIAGNOSTIC_TEST

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.

Point of Care cTnL testing

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cincinnati: lead
• Abbott: collaborator
• Jewish Hospital, Cincinnati, Ohio: collaborator
• University of Pennsylvania: collaborator
• Stanford University: collaborator
• Mayo Clinic: collaborator

Study Sites (4)

Stanford University

Stanford, California, 94305-6203, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

The Jewish Hospital

Cincinnati, Ohio, 45236, United States

Location

The University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6205, United States

Location

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.

MeSH Terms

Conditions

Angina, Unstable; Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Walter B Gibler, MD

  University of Cincinnati

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Chairman

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: December 1, 2004
• Primary Completion: November 1, 2006
• Study Completion: March 1, 2007
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

US (4)