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

NCT ID: NCT03079791

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2023-01-31

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.

Conditions

Transplant; Failure, Heart

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LMU Klinikum

OTHER

Sponsor Role: lead

Responsible Party

Steffen Massberg

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steffen Massberg, MD

Role: PRINCIPAL_INVESTIGATOR

LMU Munich

Locations

Munich University Hospital

Munich, Bavaria, Germany

Countries

Germany

Other Identifiers

GE MucI001-16

Identifier Type: -

Identifier Source: org_study_id