Computed Tomographic Coronary Angiography for Acute Chest Pain Evaluation

Coronary Artery Disease Clinical Trial

— EDCCTA  

Official title:

Utility of 64-slice Multidetector CT Coronary Angiography in the Evaluation of Low to Intermediate Risk ED Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00615719
• Other study ID #: 20061756
• Secondary ID: PT101207
• Status: Terminated
• Phase: N/A
• First received: December 25, 2007
• Last updated: December 7, 2011
• Start date: October 2006
• Est. completion date: December 2009

Study information

• Verified date: December 2011
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	VCU Medical Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Presence of Acute Coronary Syndromes(ACS).	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.	During the presenting illness, usually within two to three days.	No