Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain

NCT ID: NCT00273832

Last Updated: 2006-01-09

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

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Over 6 million patients per year visit hospital emergency departments for evaluation of chest pain, with diagnostic costs estimated to be in excess of $10 billion. Standard diagnostic evaluation often includes 8-12 hours of serial laboratory tests followed by stress imaging studies requiring an additional 4-8 hours.

Multi-slice coronary artery computed tomography scanning (MSCT) has been shown to be a highly accurate diagnostic method in comparison to invasive angiography. Because of its speed and high negative predictive value, MSCT could rapidly screen patients for the presence of coronary disease, which may expedite their care.

This study compares the length of stay and cost of care in emergency chest pain patients randomly assigned to initial evaluation by MSCT compared to patients randomly assigned to a standard diagnostic evaluation including single photon emission computed tomography scanning. The study follows these patients to detect major adverse cardiac events including unstable angina, acute myocardial infarction or death over a 90-day period.

Conditions

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Chest Pain Angina Pectoris Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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coronary artery computed tomography angiogram

Intervention Type PROCEDURE

single photon emission computed tomography

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Minestrelli Advanced Cardiac Research Imaging Center, Royal Oak, Michigan

UNKNOWN

Sponsor Role collaborator

William Beaumont Hospitals

OTHER

Sponsor Role lead

Principal Investigators

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Gilbert L Raff, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

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William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 9862943 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12383588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16053973 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9631967 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17320744 (View on PubMed)

Other Identifiers

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HIC - 2005 - 010

Identifier Type: -

Identifier Source: org_study_id