Status:
UNKNOWN
Non-invasive Test for Acute Rejection Identification in Heart Transplanted Patients
Lead Sponsor:
Myway Gentics Srl
Collaborating Sponsors:
Fondazione IRCCS Policlinico San Matteo di Pavia
Istituto Di Ricerche Farmacologiche Mario Negri
Conditions:
Acute Rejection of Cardiac Transplant
Eligibility:
All Genders
18-70 years
Brief Summary
Aim of the study is to test INNOGRAFT Heart Suite in a clinical setting, using a previously collected set of plasma samples from patients who underwent heart transplant and routinely or symptoms-based...
Detailed Description
Aim of the study is to test INNOGRAFT Heart Suite in a clinical setting, using a previously collected set of plasma samples from patients who underwent heart transplant and routinely or symptoms-based...
Eligibility Criteria
Inclusion
- To be eligible for the study, patients must fulfill all the following inclusion criteria.
- Age≥18 years;
- Heart transplanted during 2016-2019 and under surveillance for preventing acute rejection;
- Heart transplanted before 2016 but undergoing routinely or symptom-based surveillance for preventing acute rejection;
- Signed written informed consent for reuse of biosamples for research purposes; OR Signed written informed consent for study partecipation;
- Underwent at least 1 blood sampling at the same time of the EMB;
- Clinical data collected during at least 1 surveillance visit (same time of blood sampling and EMB) available;
- Availability of EMB readings for EMB performed at the same time of blood sampling.
Exclusion
- They were subjected to re-transplantation
- They were subjected to multi-organ transplantation
Key Trial Info
Start Date :
February 3 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2020
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04274712
Start Date
February 3 2020
End Date
September 1 2020
Last Update
February 18 2020
Active Locations (1)
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1
IRCCS Fondazione Policlinico San Matteo
Pavia, Italy, 27100