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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03079791

Acronym

IMPROVE-OCT

Enrollment

100

Registered

2017-03-14

Start date

2016-07-31

Completion date

2023-01-31

Last updated

2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplant; Failure, Heart

Keywords

OCT, cardiac allograft vasculopathy, CAV, intravascular imaging

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Germany

Outcome results