Clinical trial NCT05034588: Cardiac MRI for the Detection of Myocardial Injury Following Acute Kidney Injury
Official title: Multiparametric Cardiac MRI for the Detection and Quantification of Myocardial Injury Following Acute Kidney Injury (Cardiorenal Syndrome Type 3)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Cardio-Renal Syndrome
Cardiomyopathies
Keywords: Cardiac MRI
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Myocardial T1 relaxation time
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
Secondary outcomes:
measure: Myocardial T2 relaxation time
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
measure: Myocardial ECV
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
measure: Myocardial strain
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
state: NRW
city: Bonn
country: Germany
facility: University Hospital Bonn, Department of Anesthesiology and Intensive Care Medicine
state: NRW
Study officials:
References: