Evaluation of a New Non-Invasive Device for Detection of Endothelial Dysfunction

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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

Official Title
-----------------
Evaluation of a New Non-Invasive Device for Detection of Endothelial Dysfunction

Conditions
-----------------
Endothelial Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female between the ages of 18-65. Ambulatory 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. Exclusion Criteria: Below age 18 and above age 65. Pregnancy 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>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<br>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<br>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 | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endothelial Dysfunction, FMD