Acute Kidney InjuryNCT05034588
Cardiac MRI for the Detection of Myocardial Injury Following Acute Kidney Injury
An observational study of Acute Kidney Injury and Cardio-Renal Syndrome, run by University Hospital, Bonn at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Kidney Injury, Cardio-Renal Syndrome, Cardiomyopathies
- What is being tested?
- Cardiac magnetic resonance scan
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- 7 Apr 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
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.
Who may be able to join
- acute kidney injury and convalescence (GFR > 45 ml/min/1.73m²).
- patients who are 18 years of age or older
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
Bonn, North Rhine-Westphalia, 53127
Julian A Luetkens, PD Dr., julian.luetkens@ukbonn.de
Alexander Isaak, Dr., alexander.isaak@ukbonn.de
- Recruiting
University Hospital Bonn, Department of Anesthesiology and Intensive Care Medicine
Bonn, North Rhine-Westphalia, 53127
Stefan Kreyer, Dr., stefan.kreyer@ukbonn.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Kidney Injury, Cardio-Renal Syndrome, Cardiomyopathies
- Being tested
- Cardiac magnetic resonance scan
- Keywords
- Cardiac MRI
- Medical subject headings
- Acute Kidney Injury, Cardio-Renal Syndrome, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonance scanDiagnostic test
Multiparametric cardiac magnetic resonance, including functional and structural parameter
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Diagnostic Test: Cardiac magnetic resonance scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: Measurement will be performed within 2 weeks after MRI scan.
Secondary outcomes (3)
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].
Measured: 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 [%].
Measured: 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.
Measured: Measurement will be performed within 2 weeks after MRI scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start7 Apr 2021
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Alexander Luetkens, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034588
- Sponsor's protocol ID
- 519/20
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37119085
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Cardiac MRI for the Detection and Quantification of Myocardial Injury Following Acute Kidney Injury (Cardiorenal Syndrome Type 3)
- ClinicalTrials.gov ID
- NCT05034588
- Acronym / sponsor ID
- 519/20
- Conditions
- Acute Kidney Injury, Cardio-Renal Syndrome, Cardiomyopathies
- Keywords
- Cardiac MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensiv care patients after acute kidney injury | – | Diagnostic Test: Cardiac magnetic resonance scanPatients 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). |
| Intensiv care patients without kidney injury | – | Diagnostic Test: Cardiac magnetic resonance scanPatients with condition after intensive care stay and subsequent convalescence (without kidney injury and preexisting underlying cardiac disease or other disease with potential cardiac involvement). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- acute kidney injury and convalescence (GFR > 45 ml/min/1.73m²).
- patients who are 18 years of age or older
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac magnetic resonance scanMultiparametric cardiac magnetic resonance, including functional and structural parameter | Diagnostic test | Intensiv care patients after acute kidney injury, Intensiv care patients without kidney injury |
Primary outcome
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].
3 secondary outcomes
Myocardial T2 relaxation time
Time frame: 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 strain
Time frame: Measurement will be performed within 2 weeks after MRI scan.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Derived from this study: PubMed 37119085Isaak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Cardio-Renal Syndrome, run by University Hospital, Bonn at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julian A Luetkens, PD Dr. med. (+49 228 287-15960, julian.luetkens@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial T1 relaxation time (time frame: Measurement will be performed within 2 weeks after MRI scan.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05034588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.