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

This study has been terminated.
(Enrollment rate was too slow.)
Sponsor:
Collaborator:
Bracco Diagnostics, Inc
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00615719
First received: December 25, 2007
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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
Acute Coronary Syndromes
Coronary Artery Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • The Presence of Acute Coronary Syndromes(ACS). [ Time Frame: During the presenting illness, usually within two to three days. ] [ Designated as safety issue: No ]
    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.


Enrollment: 35
Study Start Date: October 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
ED patients undergoing coronary CTA
Emergency Department patients suspected of having acute coronary syndrome undergoing Coronary Computed Tomographic angiography.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615719

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

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00615719     History of Changes
Other Study ID Numbers: 20061756, PT101207
Study First Received: December 25, 2007
Results First Received: August 15, 2011
Last Updated: December 7, 2011
Health Authority: United States: Institutional Review Board

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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014