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
  Purpose

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


Condition
Cardiac Transplant

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Cytokine Profiling of Cardiac Transplant Recipients

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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


Enrollment: 34
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643564

Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Peter M Eckman, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01643564     History of Changes
Other Study ID Numbers: 1111M06547
Study First Received: July 16, 2012
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Transplant
Cytokines
Graft Dysfunction

ClinicalTrials.gov processed this record on April 22, 2014