NCT00855231

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

3 years

First QC Date

March 3, 2009

Last Update Submit

November 22, 2017

Conditions

Keywords

Acute coronary syndromeCoronary artery diseasecardiac imagingcomputed tomography

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of CT compared to standard of care evaluation

    3 months

Secondary Outcomes (1)

  • Cost savings of CT-based evaluation compared to the standard of care evaluation

    3 months

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Alll patients presenting to the University of Washington Medical Center Emergency Department with possible acute coronary syndrome

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (7)

  • 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.

    PMID: 23617513BACKGROUND
  • 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.

    PMID: 23613797BACKGROUND
  • 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.

    PMID: 22209422BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Chest PainAcute Coronary SyndromePulmonary EmbolismAortic DissectionCoronary Artery Disease

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisDissection, Blood VesselAneurysmAcute Aortic SyndromeAortic DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Kelley R Branch, MD

    University of Washington

    PRINCIPAL INVESTIGATOR
  • William P Shuman, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 4, 2009

Study Start

July 1, 2006

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

November 27, 2017

Record last verified: 2017-11

Locations