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BIIR Gene to Manage Heart Allograft Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929785
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Tracking Information
First Submitted Date January 31, 2013
First Posted Date August 28, 2013
Last Update Posted Date January 13, 2016
Study Start Date December 2009
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 23, 2013)
To systematically collect blood samples from heart allograft recipients who are 0-2 years post-transplant to create a repository for genomic research. [ Time Frame: 2 years ]
To systematically collect blood samples from heart allograft recipients who are 0 -2 years post-transplant for eventual screening of blood cell gene activity, in order to identify diagnostically useful biomarkers that can help distinguish among multiple possible clinical presentation, e.g., acute rejection, antibody mediated rejection, infection, coronary artery disease, a variety of potential causes for heart dysfunction.).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 23, 2013)
Recent work using our gene expression profiling (GEP) has shown that peripheral blood cells display a unique GEP that is 90% accurate for detection of acute rejection in liver transplant patients & hopefully hearts as well. [ Time Frame: 2 years ]
Recent work using our gene expression profiling (GEP) has shown that peripheral blood cells display a unique GEP that is 90% accurate for detection of acute rejection in liver transplant patients. The Investigators hypothesize that heart allograft recipients will display a similar pattern (Aim #2). The Investigators will retrospectively select longitudinal samples collected in Aim #1 from patients who did not experience rejection and from those who did, in order to determine if their GEP correlates with what we have observed for liver patients.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 23, 2013)
  • To correlate the BUMC GEP results with AlloMap results. [ Time Frame: 2 years ]
    To correlate the BUMC GEP results with with AlloMap results. The Investigators will retrospectively select longitudinal samples collected in Aim #1 from patients who had normal vs. high AlloMap scores
  • To determine whether immune response status, as reflected by donor specific antibody response adn Cylex ImmuKnow assay, alters the GEP in heart transplant patients. [ Time Frame: 2 years ]
    To determine whether immune response status, as reflected by donor specific antibody response and Cylex ImmuKnow assay, alters the GEP heart transplant patients.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title BIIR Gene to Manage Heart Allograft Patients
Official Title Application of In-House Developed Nanomedicine Technology for Diagnosis and Management of Post-Transplant Heart Allograft Patients
Brief Summary This is a single center observational study. Duration of the study is 1 year. Participants will be followed in 2 groups. Group 1 will include all patients who have undergone a heart transplant, through the first year post transplant. Group 2 will include heart transplant recipients from 1 year to 2 years post transplant. Groups will be enrolled simultaneously. It is anticipated each group will have 25 participants.
Detailed Description Application of the BIIR gene expression profile approach to heart transplantation clinical diagnostic issues is likely to create new means to detect rejection at the earliest stages, to help prevent progression through earlier treatment, to discover new avenues targets for treatment of heart graft rejection, and to reduce the cost of post-transplant health care
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
To create new means to detect rejection at the earliest stages, to help prevent progression through earlier treatment, to discover new avenues targets for treatment of heart graft rejection, and to reduce the cost of post-transplant health care
Sampling Method Probability Sample
Study Population heart transplant patients from Baylor University Medical Center,Dallas
Condition Cardiac Transplant Failure
Intervention Not Provided
Study Groups/Cohorts
  • Pre and Post Transplant
    Research blood samples will be drawn pre-transplant, and at monthly post transplant visits at times corresponding to post-transplant, standard of care ImmKnowo and AlloMap clinical testing. A minimum of 12 visits per patient is expected
  • One year post transplant
    The second group will include heart transplant recipients at one year post transplant who consent to participate in the study. Research blood samples will be drawn at quarterly post transplant visits (standard of care in Year 2 post transplant) corresponding to ImmunKnow and AlloMap testing. A minimum of 4 visits per patient is expected.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 12, 2016)
56
Original Estimated Enrollment
 (submitted: August 23, 2013)
25
Actual Study Completion Date November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients who will have or have already received a heart transplant.
  • Patients who have no other transplant history.
  • Men and Women ages 18 to 73

Exclusion Criteria:

  • Patients who are pregnant or lactating will not be eligible for this protocol.
  • Patients who are cognitively impaired
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 73 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01929785
Other Study ID Numbers 009-265
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Baylor Research Institute
Study Sponsor Baylor Research Institute
Collaborators Not Provided
Investigators
Study Chair: Shelley Hall, MD Baylor Health Care System
PRS Account Baylor Research Institute
Verification Date January 2016