Acute Chest Pain Imaging in Emergency Department With Combined Approach of Coronary CT Angiography and CT Myocardial Perfusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Length of stay
研究概览
简要总结
This is a prospective open label two arms clinical trial. ARM-A patients will receive the standard of care diagnostic test at Baptist Hospital Main (BHM), which includes Single Photon Emission Computed Tomography (SPECT) imaging, while ARM-B patients will be randomized sequentially into two groups; Group-1 will receive CT Angiography and CT myocardial perfusion with new Revolution CT scanner (General Electric Healthcare) while the Group-2 will receive SPECT imaging test; both groups of ARM-B at West Kendall Baptist Hospital (WKBH). The primary hypothesis is that the combined evaluation of CT angiography with CT myocardial perfusion is more efficient in detecting or excluding acute coronary syndrome resulting in early discharge and decrease length of stay of patients from the Emergency Department (ED) compared to a strategy with SPECT alone. The secondary hypothesis is that a strategy with CTA/CTP can reduce direct patient care costs and potentially improve patient outcomes in the same patient population when compared to a strategy with SPECT imaging alone.
The main purpose of this study is to have a definite ED chest pain admission triage, which will help to reduce the length of stay and direct patient cost. This approach will reduce the economic burden in intermediate risk group patients as well. We had a Baptist statistician run the numbers. This study will provide important preliminary data to guide clinical implementation of CTP/CTA in clinical practice. We divided arm B into two groups as the CT protocol might be different at each hospital, so we want to reduce bias as a result of variation in clinical patterns in the different hospitals. Also, we kept 50 patients in arm A (Baptist hospital) to have a control group at the hospital level.
详细描述
BACKGROUND AND RATIONALE:
Due to the subjectivity of clinical symptoms and the indirect nature of established ischemia tests, effective initial triage of patients in the ED with acute new onset chest pain is difficult and leads to a high number of patients that are admitted to the hospital despite not having obstructive coronary disease. In the subsequent work up, these patients require extensive testing with significant resource consumption and sometimes delayed treatment. The ability to obtain information on the presence of coronary artery stenoses and plaque early in a noninvasive fashion could substantially enhance initial triage in the ED for these patients.
A combined approach as proposed here using CT coronary angiography to assess the coronary morphology together with CT myocardial perfusion assessment would address morphology and function and help to more correctly characterize coronary lesions for decision making of a potential coronary intervention.
Coronary CTA Analysis:
MDCT data sets are assessed qualitatively for the presence of coronary disease within all coronary segments, including side branches. The assessment is performed on original axial source images; thin slice (5mm) MIP's and MPR reconstructions orthogonal and perpendicular to the vessel centerline, and short axis cross-sectional reconstructions (0.625-mm-thickness). The analysis is performed per segment and per patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is > 35 years of age.
- •The patient had an episode of chest pain at rest or during exercise within the previous 24 hours.
- •The patient is classified as "Level 3" in the 5-Level Miami Baptist Chest Pain Protocol (Cury R et al. AJR, 2012; 200: 57-65) (44) or The patient is classified as "Level 4" in the 5-Level Miami Baptist Chest Pain Protocol, and has either a 40-70% stenosis by coronary CT angiography, an Agatston Calcium Score >400, or non-evaluable segments in coronary CT angiography due to calcifications, motion artifacts, or other technical reasons. (Level 4 patients who have already been scan for CTA; will not have to repeat the CTA. Eligible Level 4 patients will only go for CT Myocardial Perfusion scan.
- •Women of childbearing potential have a negative pregnancy urine or serum test.
- •The patient understands the study requirements and procedures and provides written informed consent using a form that has been approved by the Institutional Review Board (IRB) before any study specific test or procedures are performed.
- •The patient is willing to comply with the specified follow-up telephone call.
排除标准
- •The patient is classified as "Level 1", "Level 2", or "Level 5" in the 5-Level Miami Baptist Chest Pain Protocol (Cury R et al. AJR, 2012; 200: 57-65). This includes patients with STEMI (Level-1), NSTEMI or Unstable Angina (Level-2) and non-cardiac chest pain patients (Level-5)
- •Known allergy to iodinated contrast agent or creatinine >1.5mmol/L.
- •Atrial Fibrillation, Flutter or irregular heart rhythm.
- •Known history of severe asthma.
- •Body Mass Index (BMI) >
- •Patients in unstable conditions.
结局指标
主要结局
Length of stay
时间窗: First 24 to 72 hours
The average length of stay will be calculated in both study arms. Currently patients have 24 hours of stay at hospital in the chest pain observation unit. We expect and propose that with this new study the length of stay will be reduce to less than 14 hours.
次要结局
- Direct patient costs(First 24 to 72 hours)