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

Endothelial Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00650741
• Other study ID #: SMC0001
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 30, 2008
• Last updated: March 30, 2008
• Start date: February 2008

Study information

• Verified date: March 2008
• Source: Lavi Cardiatec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Endothelial Dysfunction

Locations

Country	Name	City	State
Israel	Sheba Medical Center, Heart Institutue	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Lavi Cardiatec

Country where clinical trial is conducted

Israel,