Latent class mixed modeling
OtherTo identify CAV trajectories after heart transplantation using a contemporary unsupervised trajectory-based approach known as latent class mixed modeling
NCT Number: NCT04117152
This project aims: i) to identify Cardiac Allograft Vasculopathy (CAV) trajectories after heat transplantation using latent class mixed modeling, ii) to characterize the global and specific determinants of different trajectories and iii) to provide an easily accessible tool to project individual probability of CAV trajectory belonging.
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Notify Me18 year and older
All sexes
Observational
Maarten Naesens, Leuven, Belgium
Background:
Cardiac Allograft Vasculopathy (CAV) is the third cause of late mortality and the leading cause of late allograft dysfunction. The field of heart transplantation currently lacks longitudinal description of CAV profiles. Identifying relevant CAV trajectories, or evolution profiles, and their respective determinants is an unmet clinical need. CAV trajectories requires an additional level of understanding and characterization over the current paradigm. Understanding the mechanisms and clinical factors involved in the development of CAV will be useful to provide a more nuanced picture of disease progression, which may ultimately contribute to risk stratification and ultimately guiding the care of HTx patients.
Main Outcome(s) and Measure(s):
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To identify CAV trajectories after heart transplantation using a contemporary unsupervised trajectory-based approach known as latent class mixed modeling
Time frame: 10 years post-transplant
Identification of different evolutive profiles of CAV using latent classes mixed models. Each coronary angiogram was graded from 0 (no CAV) to 3 (severe CAV) according to ISHLT classification.
Time frame: From transplantation to 1-year post-transplant
Identification of immune and non-immune determinants using multivariable multinomial logistic regression.
Time frame: 10 years post-transplant
Probability of belonging to each trajectory according to the baseline angiogram and independent risk factors for CAV
Time frame: 10 years post-transplant
Comparison of prognosis according the CAV trajectory
Paris Translational Research Center for Organ Transplantation
Other
Multicenter International Observational Study to Identify Trajectories of Cardiac Allograft Vasculopathy After Heart Transplantation and Their Specific Determinants
Acronym: TRAJ-CAV
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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