Clinical trial NCT03079791: Impact of Level and Quality of Immunosuppression on Onset and Pattern of Cardiac Allograft Vasculopathy Evaluated by OCT
Official title: Prospective Registry of Impact of Level and Quality of Immunosuppression on Onset and Pattern of Cardiac Allograft Vasculopathy Evaluated by OCT.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transplant; Failure, Heart
Keywords: OCT
cardiac allograft vasculopathy
CAV
intravascular imaging
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients after successful cardiac transplantation at the time of coronary angiography as part of routine follow-up after cardiac transplantation or as invasive diagnostic tool in case of clinical suspicion of cardiac allograft vasculopathy and indication for intravascular imaging according to guidelines.

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.

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

Primary outcomes:
measure: CAV patterns
timeFrame: 2 years
Secondary outcomes:
measure: Immunosuppression compliance
timeFrame: 2 years
measure: combined ischemic events
timeFrame: 2 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Munich University Hospital
state: Bavaria
Study officials:
affiliation: LMU Munich
name: Steffen Massberg, MD
role: PRINCIPAL_INVESTIGATOR
References: