Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment (CT-STAT) - Full Text View

Sponsor:	William Beaumont Hospitals
Information provided by:	William Beaumont Hospitals
ClinicalTrials.gov Identifier:	NCT00468325

Purpose

This is a prospective, randomized multicenter trial comparing MSCT to standard of care (SOC) diagnostic treatment in the triage of Emergency Department (ED) low to intermediate risk chest pain patients. Our hypotheses are that compared to SOC treatment, MSCT is equally safe and diagnostically effective, as well as more time and cost efficient.

Condition	Intervention
Coronary Angiography Chest Pain	Procedure: Multi-slice computed tomography Procedure: Rest-stress Nuclear Myocardial Perfusion Imaging Procedure: Multi-slice Computed Tomography

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment (CT-STAT)

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Chest Pain

U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:

Diagnostic efficiency from the time to diagnosis and cost of diagosis for the CCTA and the Standard of Care [ Time Frame: Time to diagnosis ] [ Designated as safety issue: Yes ]

Enrollment:	750
Study Start Date:	May 2007
Study Completion Date:	May 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Multi-slice Computed Tomography: Active Comparator Patients admitted to the ED with chest pain and/or anginal equivalent symptoms are randomized to a multi-slice computed tomography arm where they will receive a CT scan of their heart.	Procedure: Multi-slice computed tomography Patient receives a CT scan (multi-slice computed tomography) of the heart. Procedure: Multi-slice Computed Tomography Patients admitted to the emergency department with low to intermediate chest pain receive a multi-slice computed tomographic test of the heart.
Standard of Care: Active Comparator Patients admitted to the ED with chest pain and/or anginal equivalent symptoms are randomized to the Standard of Care arm and receive rest-stress nuclear myocardial perfusion imaging test.	Procedure: Rest-stress Nuclear Myocardial Perfusion Imaging Patient receives the standard of care for emergency room admitting diagnosis of low to intermediate chest pain. A rest-stress nuclear myocardial perfusion imaging test is performed per the standard of care at each institution.

Detailed Description:

Computed tomography (CT) or "cat scan" is an x-ray test routinely used for diagnostic purposes. Heart ("Cardiac") CT, using the newest scanners, is an improved way of looking at the coronary arteries, which supply blood to the heart muscle. If these arteries are clogged this may cause chest pain or even a heart attack. The images of the coronary arteries obtained by CT scanners (during a 5-10 minute procedure) have been shown by many studies to be accurate, when compared to the conventional invasive cardiac catheterization procedure. In addition, at least five prior studies done at different hospitals suggest that cardiac CT scans are effective for diagnosing chest pain like yours in patients coming to the emergency room. What is new about this study is that it is being done in multiple hospitals at the same time. This is part of the process that all medical advances must go through to become a part of routine care of patients in hospitals throughout the country.

A standard chest pain workup typically done in the emergency department consists of a physical examination, electrocardiograms (EKGs), and several blood tests. Blood tests typically completed include cardiac enzymes (Troponin, CK & CK-MB), a kidney function test, a pregnancy test if applicable, and possibly a lipid panel, depending on physician preference. For each test, a 3mL vial will be filled with a specimen of blood and processed in the laboratory for result. Also a two-part "rest-stress" nuclear scan is typically performed, which compares blood flow into the heart tissue at rest to blood flow into the heart tissue during exercise or dilation with medications. Based on prior studies, the researchers doing the present study believe that CT scanning of the coronary arteries can provide information that is just as safe and accurate as the rest-stress nuclear scan, and can do so more rapidly at a lower cost.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Chest pain or anginal equivalent symptoms suggestive of acute coronary ischemia within the past 12 hours.
TIMI risk score less than or equal to 4.
Ability to provide informed consent.
Age greater than or equal to 25 years.

Exclusion Criteria:

Attending physician makes clinical decision for immediate invasive evaluation.
Electrographic evidence of ischemia, including acute Non ST-Elevation Myocardial Infarction (NSTEMI) or ST-Elevation Myocardial Infarction (STEMI), with ST segment elevation or depression equal to or greater than 1mm in two or more contiguous leads, and/or T wave inversion greater than or equal to 2 mm.
Positive cardiac biomarkers (troponin, CK, and/or CK-MB) compatible with AMI on initial laboratory testing, based on site standard laboratory values.
Presence of pre-existing CAD, including prior MI, prior angiographic evidence of significant CAD, defined as greater than or equal to 25% stenosis, or history of coronary artery bypass graft (CABG) surgery.
Renal insufficiency (creatinine greater than 1.5 mg/dL) or renal failure requiring dialysis.
Atrial fibrillation or other markedly irregular rhythm.
Psychological unsuitability or extreme claustrophobia.
Pregnancy or unknown pregnancy status.
Clinical instability including cardiogenic shock, hypotension (systolic blood pressure <90 mmHg), refractory hypertension (systolic blood pressure >180 mmHg on therapy), sustained ventricular or atrial arrhythmia requiring intravenous medications.
Known allergy to iodine or iodinated contrast.
Inability to tolerate beta-blocker medication, including patients with asthma or chronic obstructive pulmonary disease (COPD) requiring maintenance, i.e. use of inhaled bronchodilators or steroids, or patients with complete heart block or second-degree atrioventricular block.
Iodinated contrast administration or x-ray scan within the past 48 hours.
Use of any erectile dysfunction medications such as Viagra or Cialis in the last 24 hours.
Body Mass Index (BMI) greater than or equal to 39 kg/m2. . Use of biguanides within the past 48 hours

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468325

Locations

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, District of Columbia
Washington Hospital Center
Washington Dc, District of Columbia, United States, 20010
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Faqua Heart Center/Piedmont Hospital
Atlanta, Georgia, United States, 30309
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
William Beaumont-Troy
Troy, Michigan, United States, 48085
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
St. Paul Heart Clinic
St. Paul, Minnesota, United States, 55102
United States, New York
Mt Sinai Hospitl
New York, New York, United States, 10029
United States, Ohio
Metrohealth Medical Center
Cleveland, Ohio, United States, 44109
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Texas Heart Institute
Houston, Texas, United States, 77030
United States, Washington
MultiCare Health System-Good Samaritan Hospital
Puyallup, Washington, United States, 98371
United States, Wisconsin
Wisconsin Heart & Vascular Center
Wauwatosa, Wisconsin, United States, 53226

Sponsors and Collaborators

William Beaumont Hospitals

Investigators

Study Director:	Gilbert Raff, MD	William Beaumont Hospitals
Principal Investigator:	Kavitha Chinnaiyan, MD	William Beaumont Hospitals

More Information

No publications provided

Responsible Party:	William Beaumont Hospital ( Kavitha Chinnaiyan, MD )
Study ID Numbers:	2007-016
Study First Received:	April 30, 2007
Last Updated:	November 13, 2009
ClinicalTrials.gov Identifier:	NCT00468325 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:

coronary artery disease
chest pain
emergency room

Additional relevant MeSH terms:

Signs and Symptoms
Pain
Chest Pain

ClinicalTrials.gov processed this record on February 08, 2010