Status:
COMPLETED
Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment (CT-STAT)
Lead Sponsor:
Corewell Health East
Conditions:
Coronary Angiography
Chest Pain
Eligibility:
All Genders
25+ years
Phase:
NA
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 patient...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00468325
Start Date
May 1 2007
End Date
May 1 2009
Last Update
November 16 2009
Active Locations (16)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Cleveland Clinic Florida
Weston, Florida, United States, 33331
4
Faqua Heart Center/Piedmont Hospital
Atlanta, Georgia, United States, 30309