Cardiac MRI for the Detection of Myocardial Injury Following Acute Kidney Injury

September 2, 2021 updated by: Julian Alexander Luetkens, University Hospital, Bonn

Multiparametric Cardiac MRI for the Detection and Quantification of Myocardial Injury Following Acute Kidney Injury (Cardiorenal Syndrome Type 3)

The aim of this clinical prospective study is to assess structural and functional myocardial changes in patients after acute kidney injury (Cardiorenal syndrome type 3) and intensive care stay by multiparametric cardiac MRI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of the study is to demonstrate any differences in myocardial structure and function using multiparametric cardiac MRI in patients after acute kidney injury (Cardiorenal syndrome type 3) and intensive care stay and subsequent convalescence compared to a control group with intensive care stay but without kidney injury. Furthermore, the correlation between clinical disease severity and cardiac involvement will be investigated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • NRW
      • Bonn, NRW, Germany, 53127
        • Recruiting
        • University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
      • Bonn, NRW, Germany, 53127
        • Recruiting
        • University Hospital Bonn, Department of Anesthesiology and Intensive Care Medicine
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with convalescence after acute renal failure who were/are treated in the Department of Anesthesiology and Intensive Care Medicine of the University Hospital Bonn are included.

Description

Inclusion criteria:

  1. acute kidney injury and convalescence (GFR > 45 ml/min/1.73m²).
  2. patients who are 18 years of age or older

Exclusion criteria:

  1. underlying cardiac disease, e.g. known myocardial infarction, previous myocarditis, congenital heart disease, cardiomyopathies of other causes
  2. known underlying disease wit potential cardiac involvement, e.g. storage disease (e.g. hemochromatosis, Fabry disease), inflammatory (e.g. sarcoidosis), endocrinological (e.g. diabetes mellitus, hyper-/hypothyroidism), autoimmune (e.g. systemic lupus erythematosus, dermatomyositis, rheumatoid arthritis), therapeutic (chemotherapy).
  3. patients with persistent renal failure and GFR < 45 ml/min/1.73m²
  4. allergy to contrast media
  5. patients who are using a intrauterinpessare for contraception
  6. pregnant and breastfeeding women
  7. patients with contraindications for MRI due to implants

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Intensiv care patients after acute kidney injury
Patients with condition after intensive care stay and acute kidney injury and subsequent convalescence (without preexisting underlying cardiac disease or other disease with potential cardiac involvement).
Diagnostic test: Cardiac magnetic resonance scan
Multiparametric cardiac magnetic resonance, including functional and structural parameter
Intensiv care patients without kidney injury
Patients with condition after intensive care stay and subsequent convalescence (without kidney injury and preexisting underlying cardiac disease or other disease with potential cardiac involvement).
Diagnostic test: Cardiac magnetic resonance scan
Multiparametric cardiac magnetic resonance, including functional and structural parameter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Myocardial T1 relaxation time
Time Frame: Measurement will be performed within 2 weeks after MRI scan.
T1 relaxation times will be obtained to asses acute myocardial injury and fibrosis. T1 maps will be analyzed using a segmental approach by region of interest analysis. T1 relaxation times are given in [ms].
Measurement will be performed within 2 weeks after MRI scan.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Myocardial T2 relaxation time
Time Frame: Measurement will be performed within 2 weeks after MRI scan.
T2 relaxation times will be obtained to asses myocardial edema. T2 maps will be analyzed using a segmental approach by region of interest analysis. T2 relaxation times are given in [ms].
Measurement will be performed within 2 weeks after MRI scan.
Myocardial ECV
Time Frame: Measurement will be performed within 2 weeks after MRI scan.
Myocardial extracellular volume will be obtained to asses extracellular space/myocardial fibrosis. ECV values will be calculated using a segmental approach by region of interest analysis of native and contrast-enhanced T1 relaxation maps. ECV values are given in [%].
Measurement will be performed within 2 weeks after MRI scan.
Myocardial strain
Time Frame: Measurement will be performed within 2 weeks after MRI scan.
Cardiac magnetic resonance feature-tracking will be used to asses left ventricular longitudinal, circumferential and radial strain.
Measurement will be performed within 2 weeks after MRI scan.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bonn

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 519/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings