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Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain

Primary Purpose

Chest Pain, Angina Pectoris, Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
coronary artery computed tomography angiogram
single photon emission computed tomography
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chest Pain focused on measuring Chest pain, Angina pectoris, Emergency medicine, Spiral computed tomography, Length of stay, Cost analysis

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • William Beaumont Hospital

Outcomes

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

Full Information

First Posted
January 4, 2006
Last Updated
January 4, 2006
Sponsor
William Beaumont Hospitals
Collaborators
The Minestrelli Advanced Cardiac Research Imaging Center, Royal Oak, Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00273832
Brief Title
Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain
Official Title
Randomized Controlled Trial of Multi-Slice Coronary Computed Tomography for Evaluation of Acute Chest Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
William Beaumont Hospitals
Collaborators
The Minestrelli Advanced Cardiac Research Imaging Center, Royal Oak, Michigan

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Angina Pectoris, Myocardial Infarction
Keywords
Chest pain, Angina pectoris, Emergency medicine, Spiral computed tomography, Length of stay, Cost analysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
coronary artery computed tomography angiogram
Intervention Type
Procedure
Intervention Name(s)
single photon emission computed tomography
Primary Outcome Measure Information:
Title
Length of stay
Title
Cost of care
Secondary Outcome Measure Information:
Title
Unstable angina within 90-days
Title
Acute myocardial infarction within 90-days
Title
Cardiac death within 90-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilbert L Raff, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9862943
Citation
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.
Results Reference
background
PubMed Identifier
12383588
Citation
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.
Results Reference
background
PubMed Identifier
16053973
Citation
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.
Results Reference
background
PubMed Identifier
9631967
Citation
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.
Results Reference
background
PubMed Identifier
17320744
Citation
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.
Results Reference
derived

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Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain

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