Use of Machine-learning Algorithms, Biomarkers and Measures of Quality of Life to Personalize Medical Management of Liver and Heart Transplant Recipients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Artificial Intelligence (AI)
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Major Cardiovascular Event (MACE)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
This is an observational, low risk tissue based, non-pharmacological, retrospective-prospective study for adults heart and liver transplant patients, related to IRCCS Azienda Ospedaliero-Universitaria di Bologna (IRCCS AOUBO).
This clinical study is part of the national multicentric project DARE. The project has the wide overarching aim to develop digital solutions for personalized healthcare.
Detailed Description
This study is structured in two phases: 1) a retrospective phase that aims to develop ML-based scores that can allow to predict at patient level the risk of infections, cardiovascular diseases, new onset malignancies and chronic graft dysfunction, and describing the trajectory of this risk over time; 2) a prospective phase in which we test the association of biomarkers, QoL and frailty assessments with the ML-scores applied prospectively in heart and liver transplant recipients.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Major Cardiovascular Event (MACE)
Time Frame: 4 years
Major Cardiovascular Event (MACE) defined as, fatal or non-fatal myocardial infarction, ischemic or hemorrhagic stroke, admission for heart failure, new onset arrhythmia, new onset symptoms for peripheral artery diseases
Chronic graft dysfunction
Time Frame: 4 years
Chronic graft dysfunction; in HTX recipients defined as onset of one or more of the following: CAV grade 2 or greater as diagnosed by standard of care coronary angiography; diffuse fibrosis with signs of diastolic or systolic left ventricle dysfunction. In LTX we define chronic graft dysfunction as progressive fibrosis, cholestasis and reduced protein synthesis, portal hypertension.
Infection
Time Frame: 4 years
Infection, defined as systemic or organ-specific syndrome characterized by evidence of inflammatory response, abnormal organ function, and need for intravenous antimicrobial treatment, with or without microbiological isolate.
New onset malignancy
Time Frame: 4 years
New onset malignancy, defined as hematopoietic or solid malignant neoplasm, developing after transplantation
Secondary Outcomes
- ML-Scores as Surrogate Endpoints(4 years)