Evaluation of a New Non-Invasive Device for Detection of Endothelial Dysfunction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The purpose of the study is to investigate the sensitivity and specificity of the Endotect compared with an ultrasound device in a flow-mediated vasodilatation (FMD) test.
详细描述
The study compares the results obtained with Endotect with the results obtained from a brachial ultrasound FMD test, with and without nitroglycerin.
The results from 3 patient groups (see below) will be compared
1: 10 subjects, Half with Endothelial Dysfucntion (according to previous ultrasound FMD) , Half with no endothelial dysfucntion (according to previous ultrasound FMD), no repetition of test 2: 10 subjects, Half with Endothelial Dysfucntion (according to previous ultrasound FMD) , Half with no endothelial dysfucntion (according to previous ultrasound FMD), Repetition with Nitroglycerin 3: 10 subjects, Half with Endothelial Dysfucntion (according to previous ultrasound FMD) , Half with no endothelial dysfucntion (according to previous ultrasound FMD), repetition of test with the Endotect
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between the ages of 18-
- •FMD ultrasound assessment within past 6 months.
- •No clinical evidence of cardiovascular disease (no history of MI, TIA or stroke, limp, carotid or aortic murmurs)
- •10 hour fast - water only
- •Normal peripheral pulse examination.
- •ECG without evidence of former MI or LVH.
- •Capable of understanding the explanation and signing informed consent.
排除标准
- •Below age 18 and above age
- •Has not had FMD ultrasound assessment within past 6 months.
- •Exhibits clinical evidence of cardiovascular disease (history of MI, TIA or stroke, limp, carotid or aortic murmurs, clotting disorder)
- •Has eaten or drunk anything besides water in past 10 hours.
- •Known sensitivity to NTG
- •Takes medication for asthma, heart disease or depression, such as atenolol (Tenormin); carteolol (Cartrol); labetalol (Normodyne,Trandate); metoprolol (Lopressor); nadolol (Corgard); phenelzine (Nardil); propranolol (Inderal); sotalol (Betapace); theophylline (Theo-Dur); timolol (Blocadren); tranylcypromine (Parnate), and tricyclic antidepressants such as Elavil
- •Anemia, glaucoma, or have taken medication such as calcium channel blockers like amlodipine (Norvasc), diltiazem(Cardizem), felodipine (Plendil), isradipine (DynaCirc), nifedipine (Procardia), and verapamil (Calan, Isoptin); dihydroergotamine (D.H.E. 45)
- •Venopuncture of arms within past week
- •Use of Viagra, Levitra, Cialis or similar medications to treat erectile dysfunction within last 24 hours or planned use within 8 hours
- •Any of the following:
- •unstable emotionally
- •unable to understand explanation of study
- •ECG with evidence of former MI or LVH.
- •Abnormal peripheral pulses
- •Has not signed an informed consent form.
- •Patient is enrolled in another clinical study.