Impact of Level and Quality of Immunosuppression on Onset and Pattern of Cardiac Allograft Vasculopathy Evaluated by OCT (IMPROVE-OCT)

LMU Klinikum

Status: Completed

Conditions: Transplant; Failure, Heart

Study type: Observational

Funder types: Other

Identifiers

NCT03079791

GE MucI001-16

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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