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Cytokine Profiling Post-Heart Transplant

This study is ongoing, but not recruiting participants.
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: July 17, 2012
Last verified: July 2012
History of Changes
  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:

U.S. FDA Resources

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

Enrollment: 34
Study Start Date: November 2011
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: July 17, 2012
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 May 19, 2013