NCT05034588

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

August 27, 2021

Last Update Submit

September 2, 2021

Conditions

Keywords

Cardiac MRI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Myocardial T2 relaxation time

    Measurement will be performed within 2 weeks after MRI scan.

  • Myocardial ECV

    Measurement will be performed within 2 weeks after MRI scan.

  • Myocardial strain

    Measurement will be performed within 2 weeks after MRI scan.

Study Arms (2)

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

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

Interventions

Multiparametric cardiac magnetic resonance, including functional and structural parameter

Intensiv care patients after acute kidney injuryIntensiv care patients without kidney injury

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • underlying cardiac disease, e.g. known myocardial infarction, previous myocarditis, congenital heart disease, cardiomyopathies of other causes
  • 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).
  • patients with persistent renal failure and GFR \< 45 ml/min/1.73m²
  • allergy to contrast media
  • patients who are using a intrauterinpessare for contraception
  • pregnant and breastfeeding women
  • patients with contraindications for MRI due to implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

University Hospital Bonn, Department of Anesthesiology and Intensive Care Medicine

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Related Publications (1)

  • Isaak A, Pomareda I, Mesropyan N, Kravchenko D, Endler C, Bischoff L, Pieper CC, Kuetting D, Attenberger U, Zimmer S, Putensen C, Schewe JC, Kreyer S, Luetkens JA. Cardiovascular Magnetic Resonance in Survivors of Critical Illness: Cardiac Abnormalities Are Associated With Acute Kidney Injury. J Am Heart Assoc. 2023 May 2;12(9):e029492. doi: 10.1161/JAHA.123.029492. Epub 2023 Apr 29.

MeSH Terms

Conditions

Acute Kidney InjuryCardio-Renal SyndromeCardiomyopathies

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHeart FailureHeart DiseasesCardiovascular Diseases

Central Study Contacts

Julian A Luetkens, PD Dr. med.

CONTACT

Alexander Isaak, PD Dr. med.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Senior Physician

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 5, 2021

Study Start

April 7, 2021

Primary Completion

July 31, 2022

Study Completion

December 31, 2023

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations