Status:
UNKNOWN
Evaluation of a New Non-Invasive Device for Detection of Endothelial Dysfunction
Lead Sponsor:
Lavi Cardiatec
Conditions:
Endothelial Dysfunction
Eligibility:
All Genders
18-65 years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00650741
Start Date
February 1 2008
Last Update
April 2 2008
Active Locations (1)
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1
Sheba Medical Center, Heart Institutue
Tel Litwinsky, Israel