- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01030367
Pilot Study of Organic Nitrates on Endothelial Function in CAD Patients (ONEEF)
December 10, 2009 updated by: Julius-Maximilians University
Pilot Study of Organic Nitrates on Endothelial Progenitor Cells and Endothelial Function in Patients With Coronary Artery Disease
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bavaria
-
Würzburg, Bavaria, Germany, 97080
- Julius-Maximilians University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Coronary artery disease, 2- or 3-vessel disease
Exclusion Criteria:
- Acute myocardial infarction, acute heart failure, cancer, acute infections
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 3
|
Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day
|
Experimental: 1
PETN
|
Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day
|
Experimental: 2
ISDN
|
Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endothelial function Number of endothelial progenitor cells Function of endothelial progenitor cells
Time Frame: Baseline and after 14d
|
Baseline and after 14d
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Thum, MD, PhD, University of Würzburg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Anticipated)
November 1, 2008
Study Completion (Anticipated)
January 1, 2010
Study Registration Dates
First Submitted
December 10, 2009
First Submitted That Met QC Criteria
December 10, 2009
First Posted (Estimate)
December 11, 2009
Study Record Updates
Last Update Posted (Estimate)
December 11, 2009
Last Update Submitted That Met QC Criteria
December 10, 2009
Last Verified
January 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0001 (Cancer Research Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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