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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
PETN, ISDN
Sponsored by
Julius-Maximilians University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Coronary Artery Disease focused on measuring Coronary artery disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Julius-Maximilians University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

1

2

3

Arm Description

PETN

ISDN

Outcomes

Primary Outcome Measures

Endothelial function Number of endothelial progenitor cells Function of endothelial progenitor cells

Secondary Outcome Measures

Full Information

First Posted
December 10, 2009
Last Updated
December 10, 2009
Sponsor
Julius-Maximilians University
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1. Study Identification

Unique Protocol Identification Number
NCT01030367
Brief Title
Pilot Study of Organic Nitrates on Endothelial Function in CAD Patients
Acronym
ONEEF
Official Title
Pilot Study of Organic Nitrates on Endothelial Progenitor Cells and Endothelial Function in Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2008 (Anticipated)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Julius-Maximilians University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
PETN
Arm Title
2
Arm Type
Experimental
Arm Description
ISDN
Arm Title
3
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
PETN, ISDN
Intervention Description
Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day
Primary Outcome Measure Information:
Title
Endothelial function Number of endothelial progenitor cells Function of endothelial progenitor cells
Time Frame
Baseline and after 14d

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Coronary artery disease, 2- or 3-vessel disease Exclusion Criteria: Acute myocardial infarction, acute heart failure, cancer, acute infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Thum, MD, PhD
Organizational Affiliation
University of Würzburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Julius-Maximilians University
City
Würzburg
State/Province
Bavaria
ZIP/Postal Code
97080
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17255540
Citation
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. doi: 10.1161/01.ATV.0000258787.18982.73. Epub 2007 Jan 25.
Results Reference
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Pilot Study of Organic Nitrates on Endothelial Function in CAD Patients

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