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Completed

NCT Number: NCT03079791

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Munich University Hospital

Munich, Bavaria, 81377, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Immunosuppression compliance

    Time frame: 2 years

    Association between pattern of CAV and the appropriateness of immunosuppression as measured regularly in routine laboratory

  2. combined ischemic events

    Time frame: 2 years

    Combined incidence of death, re-transplantation, myocardial infarction, stroke and coronary revascularization

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Registry information

Official study title

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

Acronym: IMPROVE-OCT

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2017
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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