Randomized Controlled Study of a Rapid "Rule Out" Strategy Using Computed Tomography Coronary Angiogram (CTCA) Versus Traditional Care for Low- to Intermediate-Risk Emergency Department (ED) Patients With Potential Acute Coronary Syndromes (ACS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,392
- 试验地点
- 10
- 主要终点
- Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days
研究概览
简要总结
This multi-center, randomized, controlled trial conducted in Emergency Departments (ED) compares computed tomography (CT) coronary angiography with the traditional approach (usual care) for low- to intermediate-risk chest pain patients. The primary objective is to estimate the rate of major cardiac events (heart attack or cardiac death) within 30 days in trial participants in Group B who were not found to have significant coronary artery disease by CT coronary angiography. Additional evaluations will comprise health care utilization assessments, including length of hospital stay and re-admissions, cost analysis, and 1-year post-triage/presentation major cardiac event rates.
详细描述
In this study, participants with potential ACS will be randomized to traditional "rule out" care (Group A) or to traditional care plus CT coronary angiography (Group B) in a ratio of 1:2 traditional versus traditional plus CT coronary angiography.
In Group A, all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will be admitted to hospital, admitted to cardiac diagnostic unit, or discharged to home. Diagnostic testing and treatment will be decided by the team caring for the participant. Follow up will comprise telephone interviews after 30 days and 1 year from triage/presentation.
In Group B, participants will receive initial cardiac troponin and creatinine blood tests. Upon return of normal laboratory values, the participants will receive a CT coronary angiography an estimated 90 minutes after the initial values assessment or as soon as the CT scanner is available. Participants with negative test results will be discharged; follow up will comprise telephone interviews after 30 days and 1 year from triage/presentation. Participants with positive test results will be admitted to the hospital for further management dictated by the admitting team.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is 30 years of age or older
- •Participant presents with complaints consistent with potential ACS (e.g., chest pain, shortness of breath, other)
- •Participant requires admission or objective testing to exclude ACS
- •Participant with initial ECG result without acute ischemia
- •Participant with an initial Thrombolysis in Myocardial Infarction (TIMI) Risk Score of 0 to 2
- •Participant is willing to provide a written informed consent
排除标准
- •Patients who present with symptoms that are clearly not cardiac in origin (e.g., chest pain secondary to herpes zoster, obvious pneumonia, or recent trauma);
- •Patients with no initial ECG performed in the ED
- •Patients with ST-elevation myocardial infarction (STEMI)
- •Patients with existing co-morbidity that requires admission regardless of presence of ACS (e.g., uncontrolled diabetes)
- •Patients with known contraindications to CT coronary angiography: Iodinated contrast allergic-like reaction
- •Patients who are known to have had CT coronary angiography in the year prior to presentation
- •Patients who are known to have normal catheterization results (no or minimal, < 25%, stenosis) in the year prior to presentation
- •Patients who are pregnant
- •Patients with known renal insufficiency (e.g., creatinine clearance < 60 mL/min/1.73 m2)
- •Patients with no telephone or cell phone numbers (preventing follow up)
- •Patients unwilling to provide a written informed consent
研究组 & 干预措施
Traditional Strategy [Group A]
In the traditional-care arm (Group A:Standard of Care (SOC)), all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will receive disposition (admit to hospital, admit to cardiac diagnostic unit, or discharge to home), diagnostic testing (none, stress testing, or cardiac catheterization), and treatment according to the team caring for the participant.
干预措施: Traditional Strategy (Procedure)
CT Coronary Angiography (CTCA)[Group B]
In the study CT coronary angiography-based rapid "rule out" arm (Group B), participants will receive initial cardiac troponin and creatinine tests. Upon return of normal laboratory values (including a calculated creatinine clearance), the participants will receive a CT coronary angiography an estimated 90 minutes or as soon as the CT scanner is available following the initial values assessment. Participants with negative test results will be discharged unless other indications for admission per standard of care and follow up will comprise telephone interviews 30 days and 1 year after triage/presentation. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team.
干预措施: CT Coronary Angiography (CTCA) (Diagnostic Test)
结局指标
主要结局
Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days
时间窗: up to 30 days of discharge from the ED
To estimate the rate of major cardiac events (AMI or cardiac death) within 30 days of discharge from Emergency Department (ED) - patient follow-up included telephone interviews 30 days and 1 year after triage/presentation. Participants in Group B who were found not to have stenosis of the main or first order coronary branches greater than or equal to 50% by CT coronary angiography were considered negative and considered discharged if they were not designated to receive an inpatient bed or formal observation status. All myocardial infarctions were reviewed by an Adjudication Committee to confirm diagnosis.
次要结局
- Mean Length of Hospital Stay After Initial Visit(1-7 days)
- Health Care Utilization During the Index Hospitalization.(1-7 Days)
- Major Adverse Cardiac Event (MACE, Including Myocardial Infarction & Cardiac Death) and Revascularization for Participants Within 1 Year Post Triage/Presentation(Through 1-yr study follow up)
- Significant Coronary Artery Disease Detected Within Index Hospitalization as Assessed by Medical Record Review.(baseline)
- Cardiac Health Care Utilization 1 Year Post Triage/Presentation.(Through 1-yr study follow up)