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NCT01030367 Clinical Trial

Pilot Study of Organic Nitrates on Endothelial Function in CAD Patients

Coronary Artery Disease Clinical Trial

— ONEEF  

Official title:
Pilot Study of Organic Nitrates on Endothelial Progenitor Cells and Endothelial Function in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01030367
Other study ID # 0001
Secondary ID
Status Active, not recruiting
Phase N/A
First received December 10, 2009
Last updated December 10, 2009
Start date January 2007
Est. completion date January 2010

Study information
Verified date January 2007
Source Julius-Maximilians University
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

Organic nitrates increase levels of circulating endothelial progenitor cells (Thum et al., Arterioscler Thromb Vasc Biol. 2007 Apr;27(4):748-54). Here, we want to test the effects of two different organic nitrates (PETN, ISDN) on number and function of endothelial progenitor cells and endothelial function.

Description:

In this pilot study we test the effects of two different organic nitrates (PETN, ISDN) on number and function of endothelial progenitor cells and endothelial function. These parameters will be measured before and after 14d of treatment.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date January 2010
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Coronary artery disease, 2- or 3-vessel disease

Exclusion Criteria:

- Acute myocardial infarction, acute heart failure, cancer, acute infections

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• PETN, ISDN
Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day

Locations
Country Name City State
Germany Julius-Maximilians University Würzburg Bavaria

Sponsors (1)
Lead Sponsor Collaborator
Julius-Maximilians University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Thum T, Fraccarollo D, Thum S, Schultheiss M, Daiber A, Wenzel P, Munzel T, Ertl G, Bauersachs J. Differential effects of organic nitrates on endothelial progenitor cells are determined by oxidative stress. Arterioscler Thromb Vasc Biol. 2007 Apr;27(4):748-54. Epub 2007 Jan 25. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Endothelial function Number of endothelial progenitor cells Function of endothelial progenitor cells Baseline and after 14d No
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