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

May 8, 2023 updated by: Steffen Massberg, LMU Klinikum

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Munich University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAV patterns
Time Frame: 2 years
Evaluation of CAV with optical coherence tomography imaging in different follow-up timepoints according to the Heart Transplant Care guidelines
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LMU Klinikum

Investigators

  • Principal Investigator: Steffen Massberg, MD, LMU Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

March 8, 2017

First Posted (Actual)

March 14, 2017

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE MucI001-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Transplant; Failure, Heart

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