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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02670408
Ethics application status
Date submitted
22/01/2016
Date registered
1/02/2016

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
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.
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
* biopsy for clinical indications
Minimum age
18 Years
Maximum age
No limit
Sex
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
1/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
900
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
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT02670408