NCT03265535招募中不适用
Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Stress MBF
研究概览
简要总结
We propose a single-scan two-injection myocardial perfusion imaging protocol using ammonia. Subjects will undergo single-scan two-injection imaging as well as regular stress single-scan single-injection protocol and the myocardial blood flow of both techniques will be compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be ≥30 and ≤75 years of age;
- •Subjects must provide informed consent prior to study procedures;
排除标准
- •History of CAD, including:
- •Prior abnormal myocardial perfusion study
- •History of MI
- •History of angina
- •Coronary artery obstruction >50% on CTA and/or angiography
- •Left ventricular ejection fraction <50%
- •Any relative or absolute contraindication to adenosine stress, including:
- •2nd or 3rd degree heart block
- •Bradycardia (HR<50 bpm)
- •Recent acute coronary syndrome (ACS)
- •Unstable angina
- •Severe heart failure (left ventricular ejection fraction <15%)
- •Ventricular arrhythmia
- •Severe asthma and/or chronic obstructive pulmonary disease (COPD)
- •Baseline hypotension defined as systolic blood pressure < 90 mmHg
- •Caffeine intake within 24 hours prior to imaging
- •Current use of theophylline, dipyridamole, or carbamazepine
- •Allergy or intolerance to adenosine
- •Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
- •Subjects with CAD:
- •Inclusion criteria
- •Subjects must be ≥30 and ≤75 years of age;
- •Subjects must provide informed consent prior to study procedures;
- •Abnormal myocardial perfusion study within the past 12 months
- •Exclusion criteria
- •Revascularization (percutaneous coronary intervention and/or coronary artery bypass) following last myocardial perfusion study
- •Acute coronary syndrome within 30 days
- •Left ventricular ejection fraction <50%
- •Any relative or absolute contraindication to adenosine stress, including:
- •2nd or 3rd degree heart block
- •Bradycardia (HR<50 bpm)
- •Recent acute coronary syndrome (ACS)
- •Unstable angina
- •Severe heart failure (left ventricular ejection fraction <15%)
- •Ventricular arrhythmia
- •Severe asthma and/or chronic obstructive pulmonary disease (COPD)
- •Baseline hypotension defined as systolic blood pressure < 90 mmHg
- •Caffeine intake within 24 hours prior to imaging
- •Current use of theophylline, dipyridamole, or carbamazepine
- •Allergy or intolerance to adenosine
- •Any clinically significant acute or unstable physical or psychological disease, judged by the investigators, to be incompatible with the study;
- •Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
- •Female participants only: Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
- •Inability to provide written informed consent;
结局指标
主要结局
Stress MBF
时间窗: Single session (<2 hours)
Difference in stress myocardial blood flow measured by the single-scan two-injection protocol versus conventional single-scan single-injection stress protocol
次要结局
未报告次要终点
研究者
Georges El Fakhri
Director, Gordon Center for Medical Imaging
Massachusetts General Hospital
研究点 (1)
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