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

Primary Purpose

Coronary Angiography, Chest Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-slice computed tomography
Rest-stress Nuclear Myocardial Perfusion Imaging
Multi-slice Computed Tomography
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Angiography focused on measuring coronary artery disease, chest pain, emergency room

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center
  • Washington Hospital Center
  • Cleveland Clinic Florida
  • Faqua Heart Center/Piedmont Hospital
  • Northwestern Memorial Hospital
  • Massachusetts General Hospital
  • William Beaumont Hospital
  • William Beaumont-Troy
  • Minneapolis Heart Institute
  • St. Paul Heart Clinic
  • Mt Sinai Hospitl
  • Metrohealth Medical Center
  • Medical University of South Carolina
  • Texas Heart Institute
  • MultiCare Health System-Good Samaritan Hospital
  • Wisconsin Heart & Vascular Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Multi-slice Computed Tomography

Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Diagnostic efficiency from the time to diagnosis and cost of diagosis for the CCTA and the Standard of Care

Secondary Outcome Measures

Full Information

First Posted
April 30, 2007
Last Updated
November 13, 2009
Sponsor
William Beaumont Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT00468325
Brief Title
Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment (CT-STAT)
Acronym
CTSTAT
Official Title
Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment (CT-STAT)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
William Beaumont Hospitals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Angiography, Chest Pain
Keywords
coronary artery disease, chest pain, emergency room

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi-slice Computed Tomography
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Multi-slice computed tomography
Other Intervention Name(s)
MSCT, CCTA
Intervention Description
Patient receives a CT scan (multi-slice computed tomography) of the heart.
Intervention Type
Procedure
Intervention Name(s)
Rest-stress Nuclear Myocardial Perfusion Imaging
Other Intervention Name(s)
MPI, Nuclear Stress Test
Intervention Description
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
Intervention Name(s)
Multi-slice Computed Tomography
Other Intervention Name(s)
CCTA, MSCT, Ct Scan of the heart
Intervention Description
Patients admitted to the emergency department with low to intermediate chest pain receive a multi-slice computed tomographic test of the heart.
Primary Outcome Measure Information:
Title
Diagnostic efficiency from the time to diagnosis and cost of diagosis for the CCTA and the Standard of Care
Time Frame
Time to diagnosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilbert Raff, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kavitha Chinnaiyan, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Washington Hospital Center
City
Washington Dc
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Faqua Heart Center/Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
William Beaumont-Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
St. Paul Heart Clinic
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Mt Sinai Hospitl
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Metrohealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MultiCare Health System-Good Samaritan Hospital
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98371
Country
United States
Facility Name
Wisconsin Heart & Vascular Center
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21939822
Citation
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.
Results Reference
derived

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

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