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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Julius-Maximilians University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Julius-Maximilians University
ClinicalTrials.gov Identifier:
NCT01030367
First received: December 10, 2009
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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 Intervention
Coronary Artery Disease
 Drug: PETN, ISDN

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Julius-Maximilians University:

Primary Outcome Measures:
  • Endothelial function Number of endothelial progenitor cells Function of endothelial progenitor cells [ Time Frame: Baseline and after 14d ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Homepage of University  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Julius-Maximilians University
ClinicalTrials.gov Identifier: NCT01030367     History of Changes
Other Study ID Numbers: 0001
Study First Received: December 10, 2009
Last Updated: December 10, 2009
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 21, 2013