Heart TIMING - Heart Transplantation IMagING

April 13, 2018 updated by: Hajnalka Vágó MD PhD, Semmelweis University Heart and Vascular Center

Morphological and Functional Changes After Heart Transplantation - Role of Noninvasive Imaging in the Early Detection of Cardiac Allograft Rejection and Vasculopathy

The cardiac allograft rejection (CAR) and cardiac allograft vasculopathy (CAV) significantly affect the prognosis of patients after heart transplantation. The aim of the present study is to investigate and differentiate the adaptive and pathological cardiovascular changes after heart transplantation using different modalities. The investigator's main purpose is to define the role of the cardiovascular imaging methods and biomarkers in the early diagnosis of CAR and CAV.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations.
  2. Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed.
  3. Life quality questionnaire, patient history - Detailed questionnaire about personal and family history, general symptoms and life quality.
  4. Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters are planned to be measured, such as cardiac biomarkers.
  5. Endomyocardial biopsy
  6. Detailed transthoracic echocardiography including strain analysis and 3D measurement
  7. Detailed cardiac magnetic resonance (CMR) examination
  8. Coronary imaging - invasive coronarography and intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT)
  9. Invasive pressure measurement - Measurement of coronary flow reserve (CFR) and microcirculation resistance index (IMR)

Study Type

Observational

Enrollment (Anticipated)

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 Contact

  • Name: Hajnalka Vago, MD, PhD
  • Phone Number: +3620 8258058
  • Email: vagoha@gmail.com

Study Locations

  • Hungary
      • Budapest, Hungary
        • Recruiting
        • Heart And Vascular Center, Semmelweis University
        • Contact:
          • Hajnalka Vago, MD, PhD

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who underwent first cardiac transplantation.

Description

Inclusion Criteria:

  • First heart transplantation

Exclusion Criteria:

  • Cardiogenic shock on/after day 28 after heart transplantation
  • Lack of consent
  • Lack of cooperation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary allograft vasculopathy
Time Frame: 5 years
Coronary allograft vasculopathy confirmed based on IVUS/OCT
5 years
Coronary allograft rejection
Time Frame: 5 years
Coronary allograft rejection confirmed based on endomyocardial biopsy/clinical parameters
5 years

Collaborators and Investigators

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

Sponsor

Semmelweis University Heart and Vascular Center

Collaborators

National Research, Development and Innovation Fund of Hungary, Project no. NVKP_16-1-2016-0017

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)

January 15, 2018

Primary Completion (Anticipated)

January 15, 2021

Study Completion (Anticipated)

January 15, 2026

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

April 13, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 13, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Heart TIMING 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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