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临床试验/NCT00468325
NCT00468325已完成不适用

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

William Beaumont Hospitals31 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
750
试验地点
31
主要终点
Diagnostic efficiency from the time to diagnosis and cost of diagosis for the CCTA and the Standard of Care

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chest pain or anginal equivalent symptoms suggestive of acute coronary ischemia within the past 12 hours.
  • TIMI risk score less than or equal to
  • Ability to provide informed consent.
  • Age greater than or equal to 25 years.

排除标准

  • 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/m
  • . Use of biguanides within the past 48 hours

结局指标

主要结局

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

时间窗: Time to diagnosis

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (31)

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