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Pharmacokinetics of Pavaverine After Intraluminal Administration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01436981
First Posted: September 20, 2011
Last Update Posted: June 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Klinikum Ludwigshafen
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
  Purpose
The purpose of this study is to determine the pharmacokinetic of papaverine after administration into the artery mammaria interna.

Condition Intervention
Injury of Internal Mammary Artery Complications Due to Coronary Artery Bypass Graft Procedure: CABG

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on Papaverine During Cardiac Surgical Procedures

Resource links provided by NLM:


Further study details as provided by Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Maximum plasma concentration of papaverine [ Time Frame: 4 hours ]
    Serum probes will be analysed for the concentrations of papaverine.


Enrollment: 12
Study Start Date: October 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CABG with papaverine
Patients with CABG procedure
Procedure: CABG
Preparation of artery mammaria interna
Other Name: Paveron N

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
CABG patients
Criteria

Inclusion Criteria:

  • CABG
  • Administration of papaverine into mammaria interna

Exclusion Criteria:

  • Allergy against papaverine
  Contacts and Locations
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): NCT01436981


Locations
Germany
Klinikum der Goethe Universität Frankfurt
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Klinikum Ludwigshafen
Investigators
Principal Investigator: Arndt H Kiessling, MD Johann Wolfgang Goethe University Hospital
  More Information

Responsible Party: Arndt-H. Kiessling, Head cardiovascular research, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01436981     History of Changes
Other Study ID Numbers: PAV002-AHK
First Submitted: September 14, 2011
First Posted: September 20, 2011
Last Update Posted: June 4, 2013
Last Verified: June 2013

Keywords provided by Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals:
papaverine
pharmacokinetic
CABG
Injury of Internal Mammary Artery
Complications Due to Coronary Artery Bypass Graft

Additional relevant MeSH terms:
Papaverine
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Urological Agents