NCT01643564

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

Status
terminated

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

Study Start

First participant enrolled

November 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

July 16, 2012

Last Update Submit

October 2, 2023

Conditions

Cardiac Transplant

Keywords

TransplantCytokinesGraft Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection

    Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection

    12 months

Study Arms (4)

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 Criteria

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

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

You may qualify if:

  • Group 1
  • years and older
  • Cardiac Transplant recipient with graft dysfunction of unknown etiology
  • Group 2
  • years or older
  • No history of heart failure or cardiac transplantation Group 3
  • years or older
  • Class II-IV heart failure Group 4
  • years or older
  • Heart Transplant 6 months or greater prior to blood draw
  • No graft dysfunction

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Peter M Eckman, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2012

First Posted

July 18, 2012

Study Start

November 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

October 4, 2023

Record last verified: 2023-10