Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain - Full Text View

Sponsor:	William Beaumont Hospitals
Collaborator:	The Minestrelli Advanced Cardiac Research Imaging Center, Royal Oak, Michigan
Information provided by:	William Beaumont Hospitals
ClinicalTrials.gov Identifier:	NCT00273832

Purpose

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.

Condition	Intervention	Phase
Chest Pain Angina Pectoris Myocardial Infarction	Procedure: coronary artery computed tomography angiogram Procedure: single photon emission computed tomography	Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Randomized Controlled Trial of Multi-Slice Coronary Computed Tomography for Evaluation of Acute Chest Pain

Resource links provided by NLM:

MedlinePlus related topics: Angina CT Scans Chest Pain Heart Attack

U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:

Length of stay
Cost of care

Secondary Outcome Measures:

Unstable angina within 90-days
Acute myocardial infarction within 90-days
Cardiac death within 90-days

Estimated Enrollment:	200
Study Start Date:	March 2005
Estimated Study Completion Date:	November 2005

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273832

Locations

United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073

Sponsors and Collaborators

William Beaumont Hospitals

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

Investigators

Principal Investigator:

Gilbert L Raff, MD

William Beaumont Hospitals

More Information

Publications:

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.

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. No abstract available.

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.

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2007 Feb 12.

Study ID Numbers:	HIC – 2005 – 010
Study First Received:	January 4, 2006
Last Updated:	January 4, 2006
ClinicalTrials.gov Identifier:	NCT00273832 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by William Beaumont Hospitals:

Chest pain
Angina pectoris
Emergency medicine

Spiral computed tomography
Length of stay
Cost analysis

Additional relevant MeSH terms:

Heart Diseases
Myocardial Ischemia
Angina Pectoris
Vascular Diseases
Pain
Ischemia
Chest Pain

Signs and Symptoms
Necrosis
Pathologic Processes
Cardiovascular Diseases
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on November 30, 2009