Impact of Level and Quality of Immunosuppression on Onset and Pattern of Cardiac Allograft Vasculopathy Evaluated by OCT

Completed

• Conditions: Transplant; Failure, Heart

• Registration Number: NCT03079791
• Lead Sponsor: LMU Klinikum

Brief Summary

The aim of this study is to use the high resolution of optical coherence tomography to assess the prevalence of different types of cardiac allograft vasculopathy (CAV) in cardiac transplanted patients and correlate those results with the level of immunosuppression

Detailed Description

CAV is the most common reason for retransplantation at \>1 year and one of the main risk factors for mortality after cardiac transplantation. For this registry, patients planned to undergo coronary angiography either as a part of routine follow-up to screen for relevant cardiac allograft vasculopathy or because of clinical suspicion of relevant cardiac allograft vasculopathy will be considered eligible.

Since the "Transplant Care Guidelines of 2010" recommend the use of intracoronary imaging during angiographic follow-up in patients after heart transplantation to recognize CAV as early as possible, OCT has become integral part of the CAV diagnostic in our center. Through its high resolution OCT (so called virtual histology) provides the earliest possible diagnosis of CAV as well as new insights into the differentiation of CAV types. We aim to correlate the findings of OCT with the level of immunosuppression.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-14
• Primary Completion: 2023-01
• Study Completion: 2023-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients after cardiac transplantation undergoing planed routine angiographic examination and intracoronary imaging.
• Written informed consent

Exclusion Criteria

• Age < 18 years old
• Hemodynamic and/or electric instability
• Chronic kidney failure with glomerular filtration rate < 30 ml/min
• Pregnant or breastfeeding women
• Incapacity of providing informed consent
• If in the investigator's opinion the patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study or impact the scientific integrity of the study
• Any contraindication to intracoronary imaging

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CAV patterns	2 years	Evaluation of CAV with optical coherence tomography imaging in different follow-up timepoints according to the Heart Transplant Care guidelines

Secondary Outcome Measures

Name	Time	Method
combined ischemic events	2 years	Combined incidence of death, re-transplantation, myocardial infarction, stroke and coronary revascularization
Immunosuppression compliance	2 years	Association between pattern of CAV and the appropriateness of immunosuppression as measured regularly in routine laboratory

Trial Locations

Locations (1)

Munich University Hospital; 🇩🇪 Munich, Bavaria, Germany