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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05034588
• Other study ID #: 519/20
• Status: Recruiting
• Start date: April 7, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2021
• Source: University Hospital, Bonn
• Contact: Julian A Luetkens, PD Dr. med.
• Phone: +49 228 287-15960
• Email: julian.luetkens[@]ukbonn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: July 31, 2022
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardio-Renal Syndrome
• Cardiomyopathies
• Syndrome
• Wounds and Injuries

Intervention

Diagnostic Test:
• Cardiac magnetic resonance scan
Multiparametric cardiac magnetic resonance, including functional and structural parameter

Locations

Country	Name	City	State
Germany	University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology	Bonn	NRW
Germany	University Hospital Bonn, Department of Anesthesiology and Intensive Care Medicine	Bonn	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.