NCT01436981

Brief Summary

The purpose of this study is to determine the pharmacokinetic of papaverine after administration into the artery mammaria interna.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 14, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

3 months

First QC Date

September 14, 2011

Last Update Submit

June 3, 2013

Conditions

Injury of Internal Mammary ArteryComplications Due to Coronary Artery Bypass Graft

Keywords

papaverinepharmacokineticCABGInjury of Internal Mammary ArteryComplications Due to Coronary Artery Bypass Graft

Outcome Measures

Primary Outcomes (1)

  • Maximum plasma concentration of papaverine

    Serum probes will be analysed for the concentrations of papaverine.

    4 hours

Study Arms (1)

CABG with papaverine

Patients with CABG procedure

Procedure: CABG

Interventions

CABGPROCEDURE

Preparation of artery mammaria interna

Also known as: Paveron N
CABG with papaverine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

CABG patients

You may qualify if:

  • CABG
  • Administration of papaverine into mammaria interna

You may not qualify if:

  • Allergy against papaverine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum der Goethe Universität Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Study Officials

  • Arndt H Kiessling, MD

    Johann Wolfgang Goethe University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head cardiovascular research

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 20, 2011

Study Start

October 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

DE(1)