Endothelial DysfunctionNCT00650741
Evaluation of a New Non-Invasive Device for Detection of Endothelial Dysfunction
An observational study of Endothelial Dysfunction, run by Lavi Cardiatec at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who visited a clinic where FMD is performed and community sample
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Endothelial Dysfunction
- Keywords
- Endothelial Dysfunction, FMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lavi Cardiatec
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Giora Amitzur, Ph. D., Study director, Heart Institute, Sheba Medical Center and Tel Aviv University, IsraelMichael Schechter, MD MA FACC, Principal investigator, Heart Institute, Sheba Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650741
- Sponsor's protocol ID
- SMC0001
- Status last verified
- Mar 2008
- First submitted
- 30 Mar 2008
- Last updated
- 2 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Non-Invasive Device for Detection of Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT00650741
- Acronym / sponsor ID
- SMC0001
- Conditions
- Endothelial Dysfunction
- Keywords
- Endothelial Dysfunction, FMD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lavi CardiatecIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- First posted
- 2 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visited a clinic where FMD is performed and community sample
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giora Amitzur, Ph. D. study director
Heart Institute, Sheba Medical Center and Tel Aviv University, Israel
Michael Schechter, MD MA FACC principal investigator
Heart Institute, Sheba Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Dysfunction, run by Lavi Cardiatec at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2008; AzTrials last refreshed its copy on 6 Nov 2026.