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

Chest Pain Clinical Trial

— CTSTAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468325
• Other study ID #: 2007-016
• Status: Completed
• Phase: N/A
• First received: April 30, 2007
• Last updated: November 13, 2009
• Start date: May 2007
• Est. completion date: May 2009

Study information

• Verified date: November 2009
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: May 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chest Pain
• Coronary Angiography

Intervention

Procedure:
• Multi-slice computed tomography
Patient receives a CT scan (multi-slice computed tomography) of the heart.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Faqua Heart Center/Piedmont Hospital	Atlanta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Metrohealth Medical Center	Cleveland	Ohio
United States	Texas Heart Institute	Houston	Texas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Mt Sinai Hospitl	New York	New York
United States	MultiCare Health System-Good Samaritan Hospital	Puyallup	Washington
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	St. Paul Heart Clinic	St. Paul	Minnesota
United States	William Beaumont-Troy	Troy	Michigan
United States	Washington Hospital Center	Washington Dc	District of Columbia
United States	Wisconsin Heart & Vascular Center	Wauwatosa	Wisconsin
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic efficiency from the time to diagnosis and cost of diagosis for the CCTA and the Standard of Care		Time to diagnosis	Yes