NCT00273832

Brief Summary

The purpose of this study is to determine whether coronary artery computed tomography scanning is a more rapid, less expensive and safe alternative to standard diagnostic evaluation of patients with acute chest pain in the emergency room.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2

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

March 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
Last Updated

January 9, 2006

Status Verified

December 1, 2005

First QC Date

January 4, 2006

Last Update Submit

January 4, 2006

Conditions

Chest PainAngina PectorisMyocardial Infarction

Keywords

Chest painAngina pectorisEmergency medicineSpiral computed tomographyLength of stayCost analysis

Outcome Measures

Primary Outcomes (2)

  • Length of stay

  • Cost of care

Secondary Outcomes (3)

  • Unstable angina within 90-days

  • Acute myocardial infarction within 90-days

  • Cardiac death within 90-days

Interventions

coronary artery computed tomography angiogramPROCEDURE
single photon emission computed tomographyPROCEDURE

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chest pain or angina equivalent symptoms.
  • Age ≥ 25 years.
  • Low risk of infarction and/or complications by Goldman/Reilly criteria.

You may not qualify if:

  • Known coronary artery disease.
  • Electrocardiogram diagnostic of acute cardiac ischemia and/or infarction.
  • Elevated serum biomarkers including creatine kinase (CK) MB, myoglobin, and/or cardiac troponin I on initial testing.
  • Contraindication to iodinated contrast and/or beta blocking drugs.
  • Atrial fibrillation or markedly irregular rhythm.
  • Pregnancy.
  • Renal insufficiency, creatinine \> 1.5 mg/dL.
  • Iodinated contrast within prior 48 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (5)

  • Farkouh ME, Smars PA, Reeder GS, Zinsmeister AR, Evans RW, Meloy TD, Kopecky SL, Allen M, Allison TG, Gibbons RJ, Gabriel SE. A clinical trial of a chest-pain observation unit for patients with unstable angina. Chest Pain Evaluation in the Emergency Room (CHEER) Investigators. N Engl J Med. 1998 Dec 24;339(26):1882-8. doi: 10.1056/NEJM199812243392603.

    PMID: 9862943BACKGROUND

  • Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE 3rd, Steward DE, Theroux P, Gibbons RJ, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Smith SC Jr; American College of Cardiology; American Heart Association. Committee on the Management of Patients With Unstable Angina. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction--summary article: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee on the Management of Patients With Unstable Angina). J Am Coll Cardiol. 2002 Oct 2;40(7):1366-74. doi: 10.1016/s0735-1097(02)02336-7. No abstract available.

    PMID: 12383588BACKGROUND

  • Raff GL, Gallagher MJ, O'Neill WW, Goldstein JA. Diagnostic accuracy of noninvasive coronary angiography using 64-slice spiral computed tomography. J Am Coll Cardiol. 2005 Aug 2;46(3):552-7. doi: 10.1016/j.jacc.2005.05.056.

    PMID: 16053973BACKGROUND

  • Zalenski RJ, Rydman RJ, Ting S, Kampe L, Selker HP. A national survey of emergency department chest pain centers in the United States. Am J Cardiol. 1998 Jun 1;81(11):1305-9. doi: 10.1016/s0002-9149(98)00159-3.

    PMID: 9631967BACKGROUND

  • Goldstein JA, Gallagher MJ, O'Neill WW, Ross MA, O'Neil BJ, Raff GL. A randomized controlled trial of multi-slice coronary computed tomography for evaluation of acute chest pain. J Am Coll Cardiol. 2007 Feb 27;49(8):863-71. doi: 10.1016/j.jacc.2006.08.064. Epub 2007 Feb 12.

    PMID: 17320744DERIVED

MeSH Terms

Conditions

Chest PainAngina PectorisMyocardial Infarction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesNecrosis

Study Officials

  • Gilbert L Raff, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2006

First Posted

January 9, 2006

Study Start

March 1, 2005

Study Completion

November 1, 2005

Last Updated

January 9, 2006

Record last verified: 2005-12

Locations

US(1)