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

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: Recruiting
• Conditions: Cardiomyopathies; Acute Kidney Injury; Cardio-Renal Syndrome
• Intervention / Treatment: Diagnostic test: Cardiac magnetic resonance scan

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: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Alexander Isaak, PD Dr. med.; Phone Number: +49 228 287-15960; Email: alexander.isaak@ukbonn.de

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: Stefan Kreyer, Dr.; Email: stefan.kreyer@ukbonn.de

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Myocardial T1 relaxation time	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

Outcome Measure	Measure Description	Time Frame
Myocardial T2 relaxation time	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	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	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

• Sponsor: University Hospital, Bonn

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 7, 2021
• Primary Completion (ANTICIPATED): July 31, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (ACTUAL): September 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Cardiac MRI
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Disease; Renal Insufficiency; Heart Failure; Syndrome; Wounds and Injuries; Acute Kidney Injury; Cardiomyopathies; Cardio-Renal Syndrome
• Other Study ID 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