Computed Tomographic Coronary Angiography for Acute Chest Pain Evaluation

NCT00615719 | Terminated Results

• 2 other identifiers: 20061756PT101207
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndromes; Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

ED patients undergoing coronary CTA

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Bracco Diagnostics, Inc: collaborator

Study Sites (1)

VCU Medical Center

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease; Chest Pain

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: John D. Grizzard
• Organization: VCU

jdgrizzard@vcu.edu

804-828-8569

Study Officials

• John D. Grizzard, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Michael C. Kontos, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2007
• First Posted: February 14, 2008
• Study Start: October 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 8, 2011
• Results First Posted: December 8, 2011

Record last verified: 2011-12

Locations

US (1)