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

Status

Unknown

Conditions

Intervention / Treatment

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

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

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

Julius-Maximilians University

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.

General Publications

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 (Researcher)

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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