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

Completed · Not applicable

Conditions studied: Coronary Angiography, Chest Pain

In brief

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.

Key facts

Study ID

NCT00468325

Run by

Corewell Health East

People needed

750

Starts

2007-05-01

Expected to finish

2009-05-01

Last updated by the study team

2009-11-16

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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