Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Agreement Between SHAPE and Pressure Catheter Measurements
研究概览
简要总结
This study will use contrast echocardiography to assess the accuracy of a new non-invasive imaging method for subharmonic aided pressure estimation (SHAPE) compared to simultaneously acquired intra-cardiac pressures measured invasively during cardiac catheterization. This study is designed to verify that contrast echocardiography using the SHAPE method, already proven in a canine model and tested in a human pilot study can be used as a surrogate for cardiac catheterization with sufficient accuracy to allow clinical applicability in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be scheduled for cardiac catheterization procedure.
- •Be at least 18 years of age.
- •Be medically stable.
- •If a female of child-bearing potential, must have a negative pregnancy test.
- •Be conscious and able to comply with study procedures.
- •Have signed Informed Consent to participate in the study.
排除标准
- •Clinically unstable patients, e.g., those who are clinically in decompensated heart failure or having active chest pain or presenting for admission with an unstable anginal syndrome
- •Patients in whom introduction of a catheter into the left ventricle is contraindicated or would potentially be dangerous, e.g., patients with active ventricular arrhythmias or with significant aortic valve stenosis where crossing the aortic valve may be difficult and not clinically necessary
- •Females who are pregnant or nursing.
- •Patients not scheduled for cardiac catheterization procedure.
- •Patients who have received an investigational drug in the 30 days before, or will receive one within 72 h after, study drug administration.
- •Patients currently on chemotherapy or with other primary cancers requiring treatment.
- •Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable.
- •Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalised urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 h following the administration of SONAZOID).
- •Patients with congenital heart defects.
- •Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.
- •Patients with respiratory distress syndrome or a contraindication to pharmacological vasodilator stress agents.
- •Patients with thrombosis within the hepatic, portal, or mesenteric veins.
研究组 & 干预措施
Sonazoid for pressure measurements
48 µl of Sonazoid microbubbles (GE Healthcare, Oslo, Norway) will be co-infused at a rate of 0.024 µl/kg body weight/minute together with a 0.9% sodium chloride solution infused at a rate of at least 2 ml/min.
干预措施: Sonazoid (Drug)
结局指标
主要结局
Agreement Between SHAPE and Pressure Catheter Measurements
时间窗: up to 1 day
The Pearson correlation coefficient was computed between the simultaneously acquired subharmonic signal and pressure catheter data (i.e., waveforms) for each participant. The Pearson correlation coefficient was used for comparing waveforms given the underlying data and pressure values used for comparisons followed a normal distribution. Values reported will be the mean Pearson correlation coefficient values between the subharmonic waveforms and pressure catheter waveforms obtained.
Error Between SHAPE and Pressure Catheter Measurements
时间窗: up to 1 day
Based on the distribution of the differences in cardiac pressure values obtained using the SHAPE technique and the clinical pressure catheter, either a two-tailed paired t test (normal distribution) or Wilcoxon signed rank test (nonnormal distribution) was used to compare the SHAPE technique to the reference standard. Bonferroni corrections were used for multiple comparisons
次要结局
未报告次要终点