Effects of Sublingual and Transdermal Administration of Nitroglycerin for Coronary CT Angiography on Image Quality
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Coronary Artery Diameter Change
研究概览
简要总结
To evaluate image quality of coronary CT angiography (cCTA) after sublingual and transdermal administration of Nitroglycerin. Aim of this prospective research study is to investigate equivalence on image quality after sublingual or transdermal Nitroglycerin administration (H0).
Furthermore, the feasibility of transdermal Nitroglycerin administration will be evaluated.
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
- Single (Outcomes Assessor)
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
- •Scheduled cCTA with contrast.
- •Able to comprehend and sign the consent form.
排除标准
- •Known hypersensitivity to glyceryl trinitrate, and related organic nitrates.
- •Acute circulatory failure associated with marked hypotension (shock).
- •Conditions associated with elevated intracranial pressure, cerebral haemorrhage and head trauma.
- •Closed-angle glaucoma.
- •Phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra®), tadalafil (Cialis), or vardenafil (Levitra) within the last 24 hours
- •Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias)
- •Critical aortic stenosis
- •Systolic blood pressure < 90 mmHg
- •Pregnant or lactating female; premenopausal women with a positive urine pregnancy test.
- •Age under 18
- •Unwilling or unable to inform consent.
研究组 & 干预措施
Sublingual Nitroglycerin spray
Sublingual Nitroglycerin spray of 0.8 mg
干预措施: Nitroglycerin (Drug)
Sublingual Nitroglycerin tablet
Sublingual Nitroglycerin tablet of 0.8 mg
干预措施: Nitroglycerin (Drug)
Nitroglycerin skin patch
Nitroglycerin skin patch of 0.8 mg/h
干预措施: Nitroglycerin (Drug)
结局指标
主要结局
Coronary Artery Diameter Change
时间窗: obtained on the same day (day 0) of nitroglycerine administration (nitroglycerine is administered during the cCTA exam appointment).
Average diameter of coronary arteries at 7 predefined locations in the proximal, mid, and distal segments of the left main, left anterior descending, left circumflex and right coronary artery. Measurements avoid areas of coronary non-calcified and calcified plaques and measured twice for each location. Proximal and distal deviation from original measurements is possible in case of plaque.
次要结局
未报告次要终点
研究者
Brian Ghoshhajra
Principal Investigator
Massachusetts General Hospital