Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain

Myocardial Infarction Clinical Trial

Official title:

Randomized Controlled Trial of Multi-Slice Coronary Computed Tomography for Evaluation of Acute Chest Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273832
• Other study ID #: HIC – 2005 – 010
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2006
• Last updated: January 4, 2006
• Start date: March 2005
• Est. completion date: November 2005

Study information

• Verified date: December 2005
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Angina Pectoris
• Chest Pain
• Myocardial Infarction

Intervention

Procedure:
• coronary artery computed tomography angiogram

• single photon emission computed tomography

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
William Beaumont Hospitals	The Minestrelli Advanced Cardiac Research Imaging Center, Royal Oak, Michigan

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay
Primary	Cost of care
Secondary	Unstable angina within 90-days
Secondary	Acute myocardial infarction within 90-days
Secondary	Cardiac death within 90-days