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

NCT ID: NCT00468325

Last Updated: 2009-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-05-31

Brief 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.

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.

Conditions

Coronary Angiography; Chest Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Multi-slice Computed Tomography

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.

Group Type: ACTIVE_COMPARATOR

Multi-slice computed tomography

Intervention Type: PROCEDURE

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

Multi-slice Computed Tomography

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Rest-stress Nuclear Myocardial Perfusion Imaging

Intervention Type: PROCEDURE

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.

Interventions

Multi-slice computed tomography

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

MSCT; CCTA; MPI; Nuclear Stress Test; CCTA; MSCT; Ct Scan of the heart

Eligibility 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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

William Beaumont Hospital

Principal Investigators

Gilbert Raff, MD

Role: STUDY_DIRECTOR

William Beaumont Hospitals

Kavitha Chinnaiyan, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Cleveland Clinic Florida

Weston, Florida, United States

Faqua Heart Center/Piedmont Hospital

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

William Beaumont-Troy

Troy, Michigan, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

St. Paul Heart Clinic

Saint Paul, Minnesota, United States

Mt Sinai Hospitl

New York, New York, United States

Metrohealth Medical Center

Cleveland, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Texas Heart Institute

Houston, Texas, United States

MultiCare Health System-Good Samaritan Hospital

Puyallup, Washington, United States

Wisconsin Heart & Vascular Center

Wauwatosa, Wisconsin, United States

Countries

United States

References

Goldstein JA, Chinnaiyan KM, Abidov A, Achenbach S, Berman DS, Hayes SW, Hoffmann U, Lesser JR, Mikati IA, O'Neil BJ, Shaw LJ, Shen MY, Valeti US, Raff GL; CT-STAT Investigators. The CT-STAT (Coronary Computed Tomographic Angiography for Systematic Triage of Acute Chest Pain Patients to Treatment) trial. J Am Coll Cardiol. 2011 Sep 27;58(14):1414-22. doi: 10.1016/j.jacc.2011.03.068.

Reference Type: DERIVED

PMID: 21939822 (View on PubMed)

Other Identifiers

2007-016

Identifier Type: -

Identifier Source: org_study_id