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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02670408




Registration number
NCT02670408
Ethics application status
Date submitted
22/01/2016
Date registered
1/02/2016
Date last updated
26/06/2020

Titles & IDs
Public title
Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation
Scientific title
Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation, a Multicenter Study (INTERHEART)
Secondary ID [1] 0 0
ATAGC 002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Transplant Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Endomyocardial biopsy

Treatment: Surgery: Endomyocardial biopsy
One of several endomyocardial biopsy bites taken as the standard of care. We are asking now for two endomyocardial biopsy bites, to determine tissue sampling variability.

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assign molecular scores (probability) of T cell mediated rejection, antibody mediated rejection in heart transplant biopsies, in a reference set of 200 biopsies - Create a molecular classifier that predicts antibody mediated and T cell mediated rejection, based on the archetypal analysis.
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Assign in real time (three working days upon biopsy receipt) molecular scores (probability) of T cell mediated rejection and antibody mediated rejection. - The molecular phenotype of a newly acquired sample predicts the histologic and clinical features of this sample when compared to the reference set.
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
- biopsy for clinical indications
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- no consent

- pregnant women

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute - Darlinghurst
Recruitment postcode(s) [1] 0 0
NSW 2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Utah
Country [3] 0 0
United States of America
State/province [3] 0 0
Virginia
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
Italy
State/province [7] 0 0
Bologna
Country [8] 0 0
Spain
State/province [8] 0 0
La Coruna

Funding & Sponsors
Primary sponsor type
Other
Name
University of Alberta
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Demonstrate the impact of the Molecular Microscope Diagnostic System as the standard of care
for heart transplant patients.
Trial website
https://clinicaltrials.gov/show/NCT02670408
Trial related presentations / publications
Parkes MD, Aliabadi AZ, Cadeiras M, Crespo-Leiro MG, Deng M, Depasquale EC, Goekler J, Kim DH, Kobashigawa J, Loupy A, Macdonald P, Potena L, Zuckermann A, Halloran PF. An integrated molecular diagnostic report for heart transplant biopsies using an ensemble of diagnostic algorithms. J Heart Lung Transplant. 2019 Jun;38(6):636-646. doi: 10.1016/j.healun.2019.01.1318. Epub 2019 Feb 6.
Public notes

Contacts
Principal investigator
Name 0 0
Philip F Halloran, MD PhD
Address 0 0
University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Konrad S Famulski, PhD
Address 0 0
Country 0 0
Phone 0 0
1 7804921725
Fax 0 0
Email 0 0
konrad@ualberta.ca
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02670408