Trifecta-Heart cfDNA-MMDx Study

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
University of Alberta
Study ID
NCT04707872
Status
Recruiting
Apply to this trial

Conditions

  • Heart Transplant Rejection

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • MMDx diagnostic test — DIAGNOSTIC_TEST
    Microarray test of gene expression in heart biopsies
  • Prospera — DIAGNOSTIC_TEST
    Donor derived cell-free DNA in patient blood
  • HLA antibody — DIAGNOSTIC_TEST
    Centralized measurement of HLA antibodies in patient blood

Study Details

Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from heart transplants.

Key Dates

Start date
Jun 1, 2021
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Heart transplant protocol and for cause biopsies
    The study population includes patients with a functioning heart transplant undergoing a biopsy for clinical indications as standard of care, or protocol biopsies of heart in high-risk patients, or follow-up after treatment.

Primary Outcome Measure

Calibration of Prospera test for T cell-mediated rejection [ Time Frame: 18 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Baptist Health Institute for Research and InnovationLittle RockArkansas72205
Victoria McIntosh Marren
[email protected]
Patrick Campbell, MD (PRINCIPAL_INVESTIGATOR)
Tampa General Hospital, 409 Bayshore Blvd.TampaFlorida33606
Kristyn Kuzianik
[email protected]
Benjamin Mackie, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Medical Center, Columbia Interventional Cardiovascular CareWest New YorkNew Jersey10032
Maria Alejandra Muñoz Cifuentes
[email protected]
Gabriel Sayer, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical Center, 3319 Rochambeau Avenue, 2nd FLThe BronxNew York10467
Renae Robinson
[email protected]
Brandon Johnson
[email protected]
Omar Saeed, MD (PRINCIPAL_INVESTIGATOR)
Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research InstituteDallasTexas75246
Aayla K Jamil, MBBS
[email protected]
Shelley Hall, MD (PRINCIPAL_INVESTIGATOR)
Cardiovascular Medicine, University of Utah HealthSalt Lake CityUtah84132
Jennifer Hong
[email protected]
Josef Stehlik, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Little Rock, AR

By research site
Baptist Health Institute for Research and Innovation· Little Rock, ARTampa General Hospital, 409 Bayshore Blvd.· Tampa, FLColumbia University Medical Center, Columbia Interventional Cardiovascular Care· West New York, NJMontefiore Medical Center, 3319 Rochambeau Avenue, 2nd FL· The Bronx, NYAnnette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research Institute· Dallas, TXCardiovascular Medicine, University of Utah Health· Salt Lake City, UT

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