Evaluation of a New Non-Invasive Device for Detection of Endothelial Dysfunction
NCT ID: NCT00650741
Last Updated: 2008-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2008-02-29
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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CROSS_SECTIONAL
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
Yes
Sponsors
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Lavi Cardiatec
INDUSTRY
Responsible Party
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Lavi Cardiatec
Principal Investigators
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Giora Amitzur, Ph. D.
Role: STUDY_DIRECTOR
Heart Institute, Sheba Medical Center and Tel Aviv University, Israel
Michael Schechter, MD MA FACC
Role: PRINCIPAL_INVESTIGATOR
Heart Institute, Sheba Medical Center, Israel
Locations
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Sheba Medical Center, Heart Institutue
Tel Litwinsky, , Israel
Countries
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Other Identifiers
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SMC0001
Identifier Type: -
Identifier Source: org_study_id