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Usefulness of CT Coronary Angiography to Evaluate ED Patients With Chest Pain (EDCCTA)
This study is currently recruiting participants.
Verified by Virginia Commonwealth University, August 2009
First Received: December 25, 2007   Last Updated: August 20, 2009   History of Changes
Sponsor: Virginia Commonwealth University
Collaborator: Bracco Diagnostics, Inc
Information provided by: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00615719
  Purpose

The purpose of this study is to evaluate whether 64-slice CT 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 Intervention
Acute Coronary Syndromes
Coronary Artery Disease
Device: 64-Slice Multidetector Coronary CT Angiography

Study Type: Interventional
Study Design: Diagnostic, Single Blind (Investigator), Single Group Assignment
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:
  • presence of acute coronary syndromes (ACS) [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2006
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CTA: Experimental Device: 64-Slice Multidetector Coronary CT Angiography
Metoprolol 5mg IV, max of 20 mg, until heart rate <65 or systolic bp <95. Nitroglycerin 0.4 mg sublingual 3 minutes prior to start of CT. Chest CT (coronary angiography) with contrast (80mL Isovue-370).

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

Contacts
Contact: Megan M. Quinn, BS, RT(R) 804-828-8196 mmquinn@vcu.edu

Locations
United States, Virginia
VCU Medical Center Recruiting
Richmond, Virginia, United States, 23219
Principal Investigator: John D. Grizzard, MD            
Principal Investigator: Michael C. Kontos, MD            
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 ( John D. Grizzard, MD )
Study ID Numbers: 20061756, PT101207
Study First Received: December 25, 2007
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00615719     History of Changes
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:
Arterial Occlusive Diseases
Coronary Disease
Pathologic Processes
Disease
Heart Diseases
Myocardial Ischemia
Syndrome
Acute Coronary Syndrome
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 08, 2010