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Cytokine Profiling Post-Heart Transplant

This study has been terminated.
(Subject Recruitment)
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01643564
First received: July 16, 2012
Last updated: January 6, 2014
Last verified: January 2014

July 16, 2012
January 6, 2014
November 2011
June 2012   (final data collection date for primary outcome measure)
Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection
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Complete list of historical versions of study NCT01643564 on ClinicalTrials.gov Archive Site
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Cytokine Profiling Post-Heart Transplant
Cytokine Profiling of Cardiac Transplant Recipients

Measurement of cytokine levels in post-cardiac transplant patients with unexplained graft dysfunction.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
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Non-Probability Sample

Cardiology Clinic and inpatient service. Normal controls are volunteers from within the community.

Cardiac Transplant
Not Provided
  • Group 1
    Heart Transplant Recipients with Unexplained Graft Dysfunction
  • Group 2
    Normal Control
  • Group 3
    Class III-IV Heart Failure
  • Group 4
    Heart Transplant Recipients with Normal Graft Function
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
34
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Group 1

  • 18 years and older
  • Cardiac Transplant recipient with graft dysfunction of unknown etiology

Group 2

  • 18 years or older
  • No history of heart failure or cardiac transplantation Group 3
  • 18 years or older
  • Class II-IV heart failure Group 4
  • 18 years or older
  • Heart Transplant 6 months or greater prior to blood draw
  • No graft dysfunction

Exclusion Criteria:

Group 1 Heart Transplant with Unexplained Graft Dysfunction

  • Cellular or antibody-mediated cardiac allograft dysfunction

Group 2 Normal Control group

  • Active infection within 1 month of blood draw
  • Known Inflammatory Disease

Group 3 Heart Failure Group

  • Active infection within 1 month of blood draw
  • Known Inflammatory Disease

Group 4 Heart Transplant with Normal Graft Function Group

  • Active infection within 1 month of blood draw
  • Known graft dysfunction
  • Known Inflammatory Disease
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01643564
1111M06547
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Principal Investigator: Peter M Eckman, MD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP