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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Lavi Cardiatec
ClinicalTrials.gov Identifier:
NCT00650741
First received: March 30, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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.


Condition
Endothelial Dysfunction

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Evaluation of a New Non-Invasive Device for Detection of Endothelial Dysfunction

Further study details as provided by Lavi Cardiatec:

Estimated Enrollment: 30
Study Start Date: February 2008
Groups/Cohorts
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  1. Male or female between the ages of 18-65.
  2. Ambulatory
  3. FMD ultrasound assessment within past 6 months.
  4. No clinical evidence of cardiovascular disease (no history of MI, TIA or stroke, limp, carotid or aortic murmurs)
  5. 10 hour fast - water only
  6. Normal peripheral pulse examination.
  7. ECG without evidence of former MI or LVH.
  8. Capable of understanding the explanation and signing informed consent.

Exclusion Criteria:

  1. Below age 18 and above age 65.
  2. Pregnancy
  3. Has not had FMD ultrasound assessment within past 6 months.
  4. Exhibits clinical evidence of cardiovascular disease (history of MI, TIA or stroke, limp, carotid or aortic murmurs, clotting disorder)
  5. Has eaten or drunk anything besides water in past 10 hours.
  6. Known sensitivity to NTG
  7. 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
  8. 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)
  9. Venopuncture of arms within past week
  10. Use of Viagra, Levitra, Cialis or similar medications to treat erectile dysfunction within last 24 hours or planned use within 8 hours
  11. Any of the following:

    • unstable emotionally
    • unable to understand explanation of study
    • ECG with evidence of former MI or LVH.
    • Abnormal peripheral pulses
  12. Has not signed an informed consent form.
  13. Patient is enrolled in another clinical study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650741

Locations
Israel
Sheba Medical Center, Heart Institutue
Tel Hashomer, Israel
Sponsors and Collaborators
Lavi Cardiatec
Investigators
Study Director: Giora Amitzur, Ph. D. Heart Institute, Sheba Medical Center and Tel Aviv University, Israel
Principal Investigator: Michael Schechter, MD MA FACC Heart Institute, Sheba Medical Center, Israel
  More Information

No publications provided

Responsible Party: Avner Amir CEO, Lavi Cardiatec
ClinicalTrials.gov Identifier: NCT00650741     History of Changes
Other Study ID Numbers: SMC0001
Study First Received: March 30, 2008
Last Updated: March 30, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Lavi Cardiatec:
Endothelial Dysfunction
FMD

ClinicalTrials.gov processed this record on August 28, 2014