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

NCT00650741 | Unknown

• 1 other identifier: SMC0001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction

Keywords

Endothelial Dysfunction; FMD

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who visited a clinic where FMD is performed and community sample

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lavi Cardiatec: lead

Study Sites (1)

Sheba Medical Center, Heart Institutue

Tel Litwinsky, Israel

Location

Study Officials

• Giora Amitzur, Ph. D.

  Heart Institute, Sheba Medical Center and Tel Aviv University, Israel

  STUDY DIRECTOR

• Michael Schechter, MD MA FACC

  Heart Institute, Sheba Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 30, 2008
• First Posted: April 2, 2008
• Study Start: February 1, 2008
• Last Updated: April 2, 2008

Record last verified: 2008-03

Locations

IL (1)