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

Transplant; Failure, Heart Clinical Trial

— IMPROVE-OCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079791
• Other study ID #: GE MucI001-16
• Status: Completed
• Start date: July 2016
• Est. completion date: January 2023

Study information

• Verified date: May 2023
• Source: LMU Klinikum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transplant; Failure, Heart
• Vascular Diseases

Locations

Country	Name	City	State
Germany	Munich University Hospital	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
LMU Klinikum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAV patterns	Evaluation of CAV with optical coherence tomography imaging in different follow-up timepoints according to the Heart Transplant Care guidelines	2 years
Secondary	Immunosuppression compliance	Association between pattern of CAV and the appropriateness of immunosuppression as measured regularly in routine laboratory	2 years
Secondary	combined ischemic events	Combined incidence of death, re-transplantation, myocardial infarction, stroke and coronary revascularization	2 years