Computed Tomographic Coronary Angiography for Acute Chest Pain Evaluation

NCT ID: NCT00615719

Last Updated: 2011-12-08

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-12-31

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.

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.

Conditions

Acute Coronary Syndromes; Coronary Artery Disease

Keywords

Chest Pain; Coronary Angiography; Acute Coronary Syndromes; Computed Tomography

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ED patients undergoing coronary CTA

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John D. Grizzard, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Michael C. Kontos, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

VCU Medical Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

PT101207

Identifier Type: OTHER

Identifier Source: secondary_id

20061756

Identifier Type: -

Identifier Source: org_study_id