Computed Tomographic Coronary Angiography for Acute Chest Pain Evaluation (EDCCTA)

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. Identifier: NCT00615719
Recruitment Status : Terminated (Enrollment rate was too slow.)
First Posted : February 14, 2008
Results First Posted : December 8, 2011
Last Update Posted : December 8, 2011
Bracco Diagnostics, Inc
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
The purpose of this study is to evaluate whether 64-slice Computed Tomographic coronary angiography is useful for rapid diagnosis or exclusion of significant coronary artery disease in patients who present to the Emergency Department with chest pain.

Condition or disease
Acute Coronary Syndromes Coronary Artery Disease

Detailed Description:

The acute coronary syndromes (ACS), which encompass unstable angina (UA) and both ST elevation and non-ST elevation myocardial infarction (STEMI and non-STEMI), are the leading cause of death in the United States. In addition, they account for a significant number of hospital admissions (300,000 per year for STEMI, >1,000,000 per year for non-ST elevation ACS). Differentiation of patients with ACS from those with chest pain due to other causes, as well as risk stratification of those within the ACS group, are critically important.

In the Emergency Department(ED), the ECG is initially used to distinguish patients with STEMI from those with non-STEMI and other ACS. Subsequent workup in non-STEMI patients is aimed at rapidly distinguishing those who require admission and possible intervention or intensive medical therapy, from those who can be safely discharged. However, because of the frequent inability to determine whether symptoms are related to an ACS during this initial ED visit, further evaluation is often needed, resulting in an estimated 5,000,000 admissions per year.

Currently, a variety of modalities are used in this process of risk stratification, with resting myocardial perfusion imaging (MPI) often assuming a central role. This modality has an overall sensitivity of 80% and an excellent negative predictive value (95-97%). Resting MPI therefore enables clinicians to safely triage low risk patients to delayed stress testing or discharge. However, as with any test, this technique has limitations, including an increased incidence of equivocal findings in obese patients, lower sensitivity in patients without ongoing symptoms, and unsuitability in patients with previous myocardial damage. Perhaps most importantly, alternative diagnoses such as aortic dissection or pulmonary embolism cannot be evaluated with myocardial perfusion imaging.

If coronary Computed Tomographic angiography (CTA) could be shown to be a robust technique in the clinical setting, it could become a powerful tool in the triage of patients with ACS. Computed Tomography (CT) of the chest is currently considered the gold standard for evaluation of the two most common serious alternative chest pain diagnoses - aortic dissection and pulmonary embolism. A single, rapid comprehensive imaging study that could reliably diagnose or exclude coronary artery disease, aortic dissection, and pulmonary embolism would allow quicker and more appropriate triage of this acutely ill population.

However, in keeping with the principles of evidence-based medicine, before comprehensive gated chest CT angiography can be recommended in preference to existing techniques, systematic comparative studies should be performed. In this study, the results of the CTA will be compared with those of the resting MPI, which is part of the standard ED evaluation of chest pain at this institution. In addition, a majority of these patients subsequently undergo stress MPI. It is therefore anticipated that the stress MPI results will also be compared with the CTA findings.

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utility of 64-slice Multidetector CT Coronary Angiography in the Evaluation of Low to Intermediate Risk ED Patients
Study Start Date : October 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

ED patients undergoing coronary CTA
Emergency Department patients suspected of having acute coronary syndrome undergoing Coronary Computed Tomographic angiography.

Primary Outcome Measures :
  1. The Presence of Acute Coronary Syndromes(ACS). [ Time Frame: During the presenting illness, usually within two to three days. ]
    The presence of ACS was determined by either cardiac angiography, nuclear perfusion imaging or a clinical course deemed consistent with ACS by final chart review. The number of participants with ACS was determined.

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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
Emergency Department patients with chest pain considered suspicious for acute coronary syndrome, who were to undergo standard nuclear perfusion imaging as part of their standard care.

Inclusion Criteria:

  • ECG negative for acute MI
  • Must be low to intermediate risk for ACS based on the initial ECG, history, and physical, in the absence of ischemic ECG changes and positive markers.
  • Must be likely to have stress MPI or coronary arteriography as part of the diagnostic evaluation.

Exclusion Criteria:

  • Creatinine > 1.5 mg/dL
  • Allergy to radiographic contrast
  • Pregnancy
  • Contraindication to beta-blocker administration
  • Inability to hold breath for 12 seconds
  • Inability to place an 18-gauge IV angiocatheter in an antecubital vein
  • Arrhythmia that will preclude gating of the CTA
  • Prior bypass surgery

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 identifier (NCT number): NCT00615719

United States, Virginia
VCU Medical Center
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Virginia Commonwealth University
Bracco Diagnostics, Inc
Principal Investigator: John D. Grizzard, MD Virginia Commonwealth University
Principal Investigator: Michael C. Kontos, MD Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University Identifier: NCT00615719     History of Changes
Other Study ID Numbers: 20061756
PT101207 ( Other Identifier: Virginia Commonwealth University )
First Posted: February 14, 2008    Key Record Dates
Results First Posted: December 8, 2011
Last Update Posted: December 8, 2011
Last Verified: December 2011

Keywords provided by Virginia Commonwealth University:
Chest Pain
Coronary Angiography
Acute Coronary Syndromes
Computed Tomography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases