NCT01030367

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 11, 2009

Status Verified

January 1, 2007

Enrollment Period

1.8 years

First QC Date

December 10, 2009

Last Update Submit

December 10, 2009

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease

Outcome Measures

Primary Outcomes (1)

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

    Baseline and after 14d

Study Arms (3)

1

EXPERIMENTAL

PETN

Drug: PETN, ISDN

2

EXPERIMENTAL

ISDN

Drug: PETN, ISDN

3

NO INTERVENTION
Drug: PETN, ISDN

Interventions

PETN, ISDNDRUG

Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day

123

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Julius-Maximilians University

Würzburg, Bavaria, 97080, Germany

Location

Related Publications (1)

  • 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.

    PMID: 17255540BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Thomas Thum, MD, PhD

    University of Würzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 2009

First Posted

December 11, 2009

Study Start

January 1, 2007

Primary Completion

November 1, 2008

Study Completion

January 1, 2010

Last Updated

December 11, 2009

Record last verified: 2007-01

Locations

DE(1)