Stress Echo Ultrasound Contrast in an Urban Safety Net Hospital to Refine Ischemia Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Rate of non-diagnostic tests between ultrasound contrast enhanced stress echocardiography and myocardial SPECT
研究概览
简要总结
The current study is designed to have broad generalizability and inform a potential shift toward greater utilization of stress echocardiography with UCA. This will be accomplished by comparing UCA stress echocardiography with myocardial SPECT among hospitalized patients presenting with atraumatic chest pain. This study seeks to demonstrate: clinical comparability of the 2 modalities (based on non-diagnostic test rates), improved care efficiency (based on length of stay), lower costs, improved provider satisfaction, and a presumed improved safety profile through the elimination of radiation exposure.
Primary Hypothesis: A strategy of routine UCA (Optison™) enhanced stress echocardiography will result in a clinically non-diagnostic test rate comparable to myocardial SPECT among patients hospitalized (inpatient or hospital observation status) with atraumatic chest pain.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- •Males or females aged ≥ 18 years
- •Evaluated for symptoms of chest discomfort or ischemic equivalent
- •Clinical indication for stress imaging, defined as one of the following clinical risk estimates for CAD based upon the Diamond and Forrester classification7:
- •Intermediate pretest probability of CAD and electrocardiogram (ECG) is clinically interpretable and patient is able to exercise
- •Intermediate pretest probability of CAD and ECG is clinically interpretable or patient is unable to exercise
- •High pretest probability of CAD regardless of ECG interpretability and ability to exercise
- •Willing and able to provide written informed consent to participate in this study
- •Agrees to remain under observation (e.g., inpatient or observational status) until all study procedures from the hospital stay are completed, and to complete a 30-day follow up call
排除标准
- •Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
- •Documented medical history or discovery during screening and/or admission of any of the following:
- •Severe aortic or mitral stenosis
- •Significant resting left ventricular outflow tract obstruction (velocity > 3 cm/s)
- •Mobile left ventricular apical thrombus
- •Acute pericarditis or pericardial tamponade
- •Ascending or thoracic aortic aneurysm that is not stable or meets surgical criteria
- •Acute decompensated congestive heart failure
- •Established severe left ventricular systolic dysfunction (left ventricular ejection fraction < 35%)
- •Definite acute coronary syndrome (e.g., unstable angina, acute myocardial infarction) as confirmed by elevated Troponin I (>0.6 ng/L) on two successive measurements or ECG changes diagnostic for unstable angina (e.g. localized ST changes) in conjunction with clinical appraisal
- •Any of the following other abnormalities on the ECG at screening:
- •Paced ventricular rhythm or complete left bundle branch block
- •Uncontrolled arrhythmias defined by frequent premature ventricular complexes (PVCs) > 10/minute, non-sustained ventricular tachycardia, or atrial fibrillation with rapid ventricular response
- •2nd or 3rd degree heart block
- •Uncontrolled hypertension defined as systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 110 mmHg at screening
- •Hemoglobin (Hb) < 7.5 mg/dL at screening or within 3 months prior to screening
- •Potassium < 3.0 mmol/L or > 5.5 mmol/L or severe electrolyte abnormality at screening that, in the opinion of the supervising physician or Investigator, makes stress testing unsafe
- •Females who are pregnant or nursing
- •Known intolerance to any of the study stress agents (dipyridamole, dobutamine) or study cardiac imaging agents (Optison, Cardiolite)
- •Weight ≥ 350lbs
- •Any physical or psychological condition that, in the opinion of the Investigator, may adversely affect the safety of the patient if enrolled in this trial.
研究组 & 干预措施
stress echocardiography
Comparative effectiveness
干预措施: UCA stress echocardiography or myocardial SPECT (Other)
Myocardial SPECT
CER
干预措施: UCA stress echocardiography or myocardial SPECT (Other)
结局指标
主要结局
Rate of non-diagnostic tests between ultrasound contrast enhanced stress echocardiography and myocardial SPECT
时间窗: Within 5 days of stress imaging
Non-diagnostic test rates will be the principal outcome of interest and are defined as those studies that do not allow a clinical decision for patient disposition (alternative non-invasive modality ordered, imaging inadequate to exclude ischemia, target heart rate not achieved, adverse side effects and test was terminated, discharge, further invasive testing such as coronary angiography) or require cardiology consultation for further evaluation.
次要结局
- Similarity in rates of cardiac catheterization and acute coronary syndrome events between UCA stress echocardiography and myocardial SPECT(by 30 +/- 7 days post-discharge)
- Shorter length of stay and lower cost of inpatient hospital care for UCA stress echocardiography than for myocardial SPECT(30 day assesment)
- Greater physician satisfaction when using UCA stress echocardiography than for myocardial SPECT(5 days)
研究者
Mori Krantz
Principal Investigator, Cardiologist, MD FACC FACP
Denver Health and Hospital Authority