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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014