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Pilot Study of Organic Nitrates on Endothelial Function in CAD Patients (ONEEF)

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ClinicalTrials.gov Identifier: NCT01030367
Recruitment Status : Unknown
Verified January 2007 by Julius-Maximilians University.
Recruitment status was:  Active, not recruiting
First Posted : December 11, 2009
Last Update Posted : December 11, 2009
Sponsor:
Information provided by:
Julius-Maximilians University

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: PETN, ISDN Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pilot Study of Organic Nitrates on Endothelial Progenitor Cells and Endothelial Function in Patients With Coronary Artery Disease
Study Start Date : January 2007
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
PETN
Drug: PETN, ISDN
Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day
Experimental: 2
ISDN
Drug: PETN, ISDN
Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day
No Intervention: 3 Drug: PETN, ISDN
Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day



Primary Outcome Measures :
  1. Endothelial function Number of endothelial progenitor cells Function of endothelial progenitor cells [ Time Frame: Baseline and after 14d ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030367


Locations
Germany
Julius-Maximilians University
Würzburg, Bavaria, Germany, 97080
Sponsors and Collaborators
Julius-Maximilians University
Investigators
Principal Investigator: Thomas Thum, MD, PhD University of Würzburg

Publications:
Responsible Party: Julius-Maximilians University
ClinicalTrials.gov Identifier: NCT01030367     History of Changes
Other Study ID Numbers: 0001
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: January 2007

Keywords provided by Julius-Maximilians University:
Coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases