Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment (CT-STAT)
CTSTAT
1 other identifier
interventional
750
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2007
Typical duration for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedFirst Posted
Study publicly available on registry
May 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedNovember 16, 2009
November 1, 2009
1.5 years
April 30, 2007
November 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic efficiency from the time to diagnosis and cost of diagosis for the CCTA and the Standard of Care
Time to diagnosis
Study Arms (2)
Multi-slice Computed Tomography
ACTIVE COMPARATORPatients 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.
Standard of Care
ACTIVE COMPARATORPatients 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.
Interventions
Patient receives a CT scan (multi-slice computed tomography) of the heart.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Faqua Heart Center/Piedmont Hospital
Atlanta, Georgia, 30309, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
William Beaumont-Troy
Troy, Michigan, 48085, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
St. Paul Heart Clinic
Saint Paul, Minnesota, 55102, United States
Mt Sinai Hospitl
New York, New York, 10029, United States
Metrohealth Medical Center
Cleveland, Ohio, 44109, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Texas Heart Institute
Houston, Texas, 77030, United States
MultiCare Health System-Good Samaritan Hospital
Puyallup, Washington, 98371, United States
Wisconsin Heart & Vascular Center
Wauwatosa, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 21939822DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilbert Raff, MD
Corewell Health East
- PRINCIPAL INVESTIGATOR
Kavitha Chinnaiyan, MD
Corewell Health East
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 30, 2007
First Posted
May 2, 2007
Study Start
May 1, 2007
Primary Completion
November 1, 2008
Study Completion
May 1, 2009
Last Updated
November 16, 2009
Record last verified: 2009-11