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Diagnostic Accuracy of Multislice CT Angiography for Acute Chest Pain

NCT ID: NCT00855231

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-09-30

Brief Summary

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The ACUTE CT trial is designed to test whether the assessment of chest structures by high-resolution multislice computed tomography (CT) provides equivalent diagnostic accuracy for patient with acute chest pain or other potential cardiac symptoms as compared to a standard of care evaluation.

Detailed Description

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Adults at low to intermediate risk of acute coronary syndrome who present to the Emergency Department with symptoms suggestive of cardiac ischemia will undergo a blinded cardiac CT followed by a standard of care (SOC) strategy. Significant coronary artery disease on CT (coronary stenosis \>50%) will be compared to an adjudicated diagnosis derived from clinical data and other diagnostic tests based on the SOC strategy. Costs for the SOC evaluation will be collected and compared to a CT-based evaluation. Patients will be followed for 3 years after enrollment to evaluate prognosis.

Conditions

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Chest Pain Acute Coronary Syndrome Pulmonary Embolism Aortic Dissection

Keywords

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Acute coronary syndrome Coronary artery disease cardiac imaging computed tomography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Low to intermediate risk of angina with a TIMI ACS Risk Score ≤ 4
* chest pain or other symptoms suggestive of ACS within 24 hours
* male ≥30 years or female ≥45 years old
* at least one cardiac risk factor
* no obvious cause for symptoms.

Exclusion Criteria

* known CAD
* ST segment elevation, new left bundle branch block or dynamic ECG changes
* creatinine ≥1.8 g/dL
* pregnant or lactating female
* hemodynamic or respiratory instability
* ongoing bronchospasm
* known iodinated contrast allergy
* atrial fibrillation or irregular heart rate
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Kelley Branch

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kelley R Branch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

William P Shuman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Branch KR, Busey J, Mitsumori LM, Strote J, Caldwell JH, Busch JH, Shuman WP. Diagnostic performance of resting CT myocardial perfusion in patients with possible acute coronary syndrome. AJR Am J Roentgenol. 2013 May;200(5):W450-7. doi: 10.2214/AJR.12.8934.

Reference Type BACKGROUND
PMID: 23617513 (View on PubMed)

Branch KR, Strote J, Shuman WP, Mitsumori LM, Busey JM, Rue T, Caldwell JH. Diagnostic accuracy and clinical outcomes of ECG-gated, whole chest CT in the emergency department. PLoS One. 2013 Apr 16;8(4):e61121. doi: 10.1371/journal.pone.0061121. Print 2013.

Reference Type BACKGROUND
PMID: 23613797 (View on PubMed)

Branch KR, Bresnahan BW, Veenstra DL, Shuman WP, Weintraub WS, Busey JM, Elliott DJ, Mitsumori LM, Strote J, Jobe K, Dubinsky T, Caldwell JH. Economic outcome of cardiac CT-based evaluation and standard of care for suspected acute coronary syndrome in the emergency department: a decision analytic model. Acad Radiol. 2012 Mar;19(3):265-73. doi: 10.1016/j.acra.2011.10.029. Epub 2011 Dec 30.

Reference Type BACKGROUND
PMID: 22209422 (View on PubMed)

May JM, Shuman WP, Strote JN, Branch KR, Mitsumori LM, Lockhart DW, Caldwell JH. Low-risk patients with chest pain in the emergency department: negative 64-MDCT coronary angiography may reduce length of stay and hospital charges. AJR Am J Roentgenol. 2009 Jul;193(1):150-4. doi: 10.2214/AJR.08.2021.

Reference Type RESULT
PMID: 19542407 (View on PubMed)

Shuman WP, Branch KR, May JM, Mitsumori LM, Strote JN, Warren BH, Dubinsky TJ, Lockhart DW, Caldwell JH. Whole-chest 64-MDCT of emergency department patients with nonspecific chest pain: Radiation dose and coronary artery image quality with prospective ECG triggering versus retrospective ECG gating. AJR Am J Roentgenol. 2009 Jun;192(6):1662-7. doi: 10.2214/AJR.08.1872.

Reference Type RESULT
PMID: 19457832 (View on PubMed)

Mitsumori LM, Wang E, May JM, Lockhart DW, Branch KR, Dubinsky TJ, Shuman WP. Triphasic contrast bolus for whole-chest ECG-gated 64-MDCT of patients with nonspecific chest pain: evaluation of arterial enhancement and streak artifact. AJR Am J Roentgenol. 2010 Mar;194(3):W263-71. doi: 10.2214/AJR.09.2788.

Reference Type RESULT
PMID: 20173125 (View on PubMed)

Shuman WP, May JM, Branch KR, Mitsumori LM, Strote JN, Green DE, Caldwell JH. Negative ECG-gated cardiac CT in patients with low-to-moderate risk chest pain in the emergency department: 1-year follow-up. AJR Am J Roentgenol. 2010 Oct;195(4):923-7. doi: 10.2214/AJR.09.3972.

Reference Type RESULT
PMID: 20858819 (View on PubMed)

Other Identifiers

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05-6337-D 03

Identifier Type: -

Identifier Source: secondary_id

27903-D

Identifier Type: -

Identifier Source: org_study_id