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

Sponsored by:	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	Phase
Coronary Angiography Chest Pain	Phase 0

MedlinePlus related topics: CT Scans Chest Pain

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment (CT-STAT)

Further study details as provided by William Beaumont Hospitals:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	750
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2008

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
Sampling Method:	Probability Sample

Study Population

Subjects greater than equal to 25 yrs of age; both genders; subjects coming into the Emergency Dept.

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	Completed
Los Angeles, California, United States, 90048
United States, District of Columbia
Washington Hospital Center	Recruiting
Washington DC, District of Columbia, United States, 20010
Contact: Marc Landsman 202-877-8545 marc.j.landsman@medstar.net
Principal Investigator: William Guy Weigold, MD
United States, Florida
Cleveland Clinic Florida	Recruiting
Weston, Florida, United States, 33331
Contact: Mary Chandy 954-659-5447 ccfresearch1@gmail.com
Principal Investigator: Michael Shen, MD
United States, Georgia
Faqua Heart Center/Piedmont Hospital	Active, not recruiting
Atlanta, Georgia, United States, 30309
United States, Illinois
Northwestern Memorial Hospital	Recruiting
Chicago, Illinois, United States, 60611
Contact: Karissa Fortney 312-926-4801 kfortney@nmh.org
Principal Investigator: Issam Mikati, MD
United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Dahlia Banerji dbanerji@partners.org
Principal Investigator: Udo Hoffman, MD
United States, Michigan
William Beaumont Hospital	Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Maryan M DeAnglis 248-898-8141 mdeanglis@beaumont.edu
Contact: Jim Wegner 248.898.3123 jwegner@beaumont.edu
Principal Investigator: Brian O'Neil, MD
William Beaumont-Troy	Recruiting
Troy, Michigan, United States, 48085
Contact: Janet Sherman 248-964-8529 jsherman@beaumont.edu
Contact: Coleen Tessmar 248.964.8524 ctessmar@beaumont.edu
Principal Investigator: Michael Gallagher, MD
United States, Minnesota
Minneapolis Heart Institute	Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Teri Walsh, RT,CRC 612-863-6288 Teri.Walsh@allina.com
Principal Investigator: John Lesser, MD
St. Paul Heart Clinic	Recruiting
St. Paul, Minnesota, United States, 55102
Contact: Jody Caniff 651-726-6970 jcanniff@stphc.com
Principal Investigator: Uma Valeti, MD
United States, New York
Mt Sinai Hospitl	Recruiting
New York, New York, United States, 10029
Contact: Aileen Leonardo-Lin 212-241-0593 aleona01@mountsinai.org
Principal Investigator: Mario Garcia, MD
United States, Ohio
Metrohealth Medical Center	Recruiting
Cleveland, Ohio, United States, 44109
Contact: Leslie Castle 216-778-4369 lcastle1@metrohealth.org
Contact: Lisa Anderson landerson@metrohealth.org
Principal Investigator: David Rosenblum, DO
United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Genny Starr 843-792-5968
Principal Investigator: J Schoeph, MD
United States, Texas
Texas Heart Institute	Active, not recruiting
Houston, Texas, United States, 77030
United States, Washington
MultiCare Health System-Good Samaritan Hospital	Recruiting
Puyallup, Washington, United States, 98371
Contact: Krystal King 253-841-4347 krystalk@cardiacstudycenter.com
Principal Investigator: Vinay Malholtra, MD
United States, Wisconsin
Wisconsin Heart & Vascular Center	Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Ann Dwyer 414-778-7836 adwyer@twhh.org
Principal Investigator: Samuel Wann, MD

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:	October 29, 2008
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

Study placed in the following topic categories:

Coronary Disease
Signs and Symptoms
Emergencies

Pain
Coronary Artery Disease
Chest Pain

Additional relevant MeSH terms:

Signs and Symptoms
Pain
Chest Pain

ClinicalTrials.gov processed this record on May 06, 2009