Myocardial InjuryNCT05408988
Neurogenic Myocardial and Lung Injury in SAH Patients
An observational study of Myocardial Injury and Lung Injury, run by Medical University of Silesia at 1 site in Poland.
Trial summary
Up to this day, little is known whether the extent of brain damage in patients with SAH correlates with the degree neurogenic myocardial injury and neurogenic lung injury. This is a prospective observational study designed to asses relationship between catecholamine surge and development of myocardial and lung injury… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Injury, Lung Injury, Subarachnoid Hemorrhage
- What is being tested?
- hs-TnT (high-sensitive cardiac troponin T) plasma concentration, CK-MB (creatine kinase myocardial band) plasma concentration and CPK (creatine phosphokinase) plasma concentration
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 22 Jan 2022to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with subarachnoid haemorrhage admitted to the Intensive Care Unit.
Who may be able to join
- patients with subarachnoid haemorrhage (both aneurysmal and non-aneurysmal) with acute consciousness disturbances (Glasgow Coma Scale < 8 pts) requiring intubation and mechanical ventilation, hospitalized in the ICU for over 24 hours
Who cannot join
- severe prior pulmonary diseases
- severe prior cardiac diseases
- death in the first 72 hours of ICU stay
- need for any extracorporeal life-saving techniques
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
University Clinical Center prof. K. Gibiński of the Medical University of Silesia in Katowice
Katowice, Silesian Voivodeship, 40-752
Łukasz Krzych, PhD, 32 789 4201, (lkrzych@sum.edu.pl
Natalia Rachfalska
About this study
Official title: The Relationship Between Urine Metanephrine Concentration and Myocardial and Lung Injury in Subarachnoid Haemorrhage Patients: a Prospective Observational Study
Up to this day, little is known whether the extent of brain damage in patients with SAH correlates with the degree neurogenic myocardial injury and neurogenic lung injury.
This is a prospective observational study designed to asses relationship between catecholamine surge and development of myocardial and lung injury in subarachnoid haemorrhage patients.
Read the detailed description
Multiple forms of brain damage, primarily, subarachnoid haemorrhage (SAH) are frequently accompanied by neurogenic myocardial injury with changes in the electrocardiogram, accompanied by the release of markers of myocardial injury. This form of cardiac dysfunction is thought to be mediated by cellular toxicity associated with catecholamine release. Central nervous system damage in the course of intracranial haemorrhage may, in a similar pathogenic pathway, lead to neurogenic lung injury. Up to this day, little is known whether the extent of brain damage in patients with SAH correlates with the degree of neurogenic myocardial injury. Moreover, it remains unknown what is the full clinical picture and duration of this type of myocardial injury and how often it co-occurs with neurogenic lung injury. Such analysis is a fundamental and most important step in optimising the treatment of these patients.
Methods: In this prospective observational study the authors aim to recruit 30 patients with subarachnoid haemorrhage, requiring hospitalization in the Intensive Care Unit. The patients will be monitored for elevation in cardiac damage markers (hs-TnT, CPK, CK-MB, NT-proBNP) and worsening of respiratory conditions, defined by need for more invasive ventilation parameters, and subsequent changes in arterial blood gas. The above mentioned parameters will be assessed every 12 hours. Additionally, the patients will be screened for an elevation in catecholamine metabolite (metanephrine) concentration in 12-hour urine collection.
Hypothesis to be tested: Myocardial and lung injury in SAH patients is timely-associated with an increase in metanephrine concentration in urine.
- Conditions
- Myocardial Injury, Lung Injury, Subarachnoid Hemorrhage
- Being tested
- hs-TnT (high-sensitive cardiac troponin T) plasma concentration, CK-MB (creatine kinase myocardial band) plasma concentration, CPK (creatine phosphokinase) plasma concentration, NT-proBNP (N-terminal prohormone of brain natriuretic peptide) plasma concentration, Metanephrine concentration in urine
- Keywords
- myocardial injury, lung injury, SAH, subarachnoid haemorrhage, metanephrine, catecholamine-induced injury, Intensive Care Unit, neurocritical care
- Medical subject headings
- Lung Injury, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hs-TnT (high-sensitive cardiac troponin T) plasma concentrationDiagnostic test
hs-TnT plasma concentration measured once every 12 hours
CK-MB (creatine kinase myocardial band) plasma concentrationDiagnostic test
CK-MB plasma concentration measured every 12 hours
CPK (creatine phosphokinase) plasma concentrationDiagnostic test
CPK plasma concentration measured every 12 hours
NT-proBNP (N-terminal prohormone of brain natriuretic peptide) plasma concentrationDiagnostic test
NT-proBNP plasma concentration measured every 12 hours
Metanephrine concentration in urineDiagnostic test
Metanephrine concentration measured in 12-hour urine collection using spectrophotometry.
| Study group | Role | What they receive |
|---|---|---|
| Patients with subarachnoid haemorrhage | Patients aged 18 or older hospitalized in the Intensive Care Unit with Subarachnoid Haemorrhage. Receives: Diagnostic Test: hs-TnT (high-sensitive cardiac troponin T) plasma concentration; Diagnostic Test: CK-MB (creatine kinase myocardial band) plasma concentration; Diagnostic Test: CPK (creatine phosphokinase) plasma concentration; Diagnostic Test: NT-proBNP (N-terminal prohormone of brain natriuretic peptide) plasma concentration; Diagnostic Test: Metanephrine concentration in urine |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital death (number of patients)
Death of the patient during the first 7 days of hospitalization.
Measured: 7 days
Number of Patients with elevation in hs-TnT levels
hs-TnT treated as myocardial injury biomarker
Measured: 7 days
Number of Patients with elevation in NT-proBNP levels
NT-proBNP treated as myocardial injury biomarker
Measured: 7 days
Number of Patients with elevation in creatine kinase levels
Creatine kinase treated as myocardial injury biomarker
Measured: 7 days
Number of Patients with elevation in creatine kinase MB levels
Creatine kinase MB treated as myocardial injury biomarker
Measured: 7 days
Number of Patients with a decrease in Horowitz index
The decrease in Horowitz index treated as a sign of need for more invasive ventilation parameters with subsequent blood gas changes
Measured: 7 days
Number of Patients with need of increased FiO2
Need of increased FiO2 treated as a sign of need for more invasive ventilation parameters with subsequent blood gas changes
Measured: 7 days
Number of Patients with need of increased PEEP values
Need of increased PEEP values treated as a sign of need for more invasive ventilation parameters with subsequent blood gas changes
Measured: 7 days
Number of Patients with need for the use of neuro-muscular blocking agents
Need for the use of neuro-muscular blocking agents treated as a sign of need for more invasive ventilation parameters with subsequent blood gas changes
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start22 Jan 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Myocardial 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Łukasz Krzych, PhD, Study chair, University Clinical Center prof. K. Gibiński of the Medical University of Silesia in Katowice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408988
- Sponsor's protocol ID
- PCN/0022/KB/206/20
- Status last verified
- Mar 2023
- First submitted
- 2 Feb 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Osgood ML. Aneurysmal Subarachnoid Hemorrhage: Review of the Pathophysiology and Management Strategies. Curr Neurol Neurosci Rep. 2021 Jul 26;21(9):50. doi: 10.1007/s11910-021-01136-9.
PubMed 34308493Hofman M, Hajder N, Duda I, Krzych LJ. A Questionnaire Survey of Management of Patients with Aneurysmal Subarachnoid Haemorrhage in Poland. Int J Environ Res Public Health. 2020 Jun 11;17(11):4161. doi: 10.3390/ijerph17114161.
PubMed 32545225Wybraniec MT, Mizia-Stec K, Krzych L. Neurocardiogenic injury in subarachnoid hemorrhage: A wide spectrum of catecholamin-mediated brain-heart interactions. Cardiol J. 2014;21(3):220-8. doi: 10.5603/CJ.a2014.0019. Epub 2014 Feb 14.
PubMed 24526502Wybraniec M, Mizia-Stec K, Krzych L. Stress cardiomyopathy: yet another type of neurocardiogenic injury: 'stress cardiomyopathy'. Cardiovasc Pathol. 2014 May-Jun;23(3):113-20. doi: 10.1016/j.carpath.2013.12.003. Epub 2013 Dec 27.
PubMed 24462197Veeravagu A, Chen YR, Ludwig C, Rincon F, Maltenfort M, Jallo J, Choudhri O, Steinberg GK, Ratliff JK. Acute lung injury in patients with subarachnoid hemorrhage: a nationwide inpatient sample study. World Neurosurg. 2014 Jul-Aug;82(1-2):e235-41. doi: 10.1016/j.wneu.2014.02.030. Epub 2014 Feb 20.
PubMed 24560705Mazeraud A, Robba C, Rebora P, Iaquaniello C, Vargiolu A, Rass V, Bogossian EG, Helbok R, Taccone FS, Citerio G. Acute Distress Respiratory Syndrome After Subarachnoid Hemorrhage: Incidence and Impact on the Outcome in a Large Multicenter, Retrospective Cohort. Neurocrit Care. 2021 Jun;34(3):1000-1008. doi: 10.1007/s12028-020-01115-x. Epub 2020 Oct 20.
PubMed 33083966Anetsberger A, Jungwirth B, Blobner M, Ringel F, Bernlochner I, Heim M, Bogdanski R, Wostrack M, Schneider G, Meyer B, Graessner M, Baumgart L, Gempt J. Association of Troponin T levels and functional outcome 3 months after subarachnoid hemorrhage. Sci Rep. 2021 Aug 9;11(1):16154. doi: 10.1038/s41598-021-95717-w.
PubMed 34373566
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Urine Metanephrine Concentration and Myocardial and Lung Injury in Subarachnoid Haemorrhage Patients: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05408988
- Acronym / sponsor ID
- PCN/0022/KB/206/20
- Conditions
- Myocardial Injury, Lung Injury, Subarachnoid Hemorrhage
- Keywords
- myocardial injury, lung injury, SAH, subarachnoid haemorrhage, metanephrine, catecholamine-induced injury, Intensive Care Unit, neurocritical care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 22 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Jun 2022 (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.
Up to this day, little is known whether the extent of brain damage in patients with SAH correlates with the degree neurogenic myocardial injury and neurogenic lung injury.
This is a prospective observational study designed to asses relationship between catecholamine surge and development of myocardial and lung injury in subarachnoid haemorrhage patients.
Detailed description
Multiple forms of brain damage, primarily, subarachnoid haemorrhage (SAH) are frequently accompanied by neurogenic myocardial injury with changes in the electrocardiogram, accompanied by the release of markers of myocardial injury. This form of cardiac dysfunction is thought to be mediated by cellular toxicity associated with catecholamine release. Central nervous system damage in the course of intracranial haemorrhage may, in a similar pathogenic pathway, lead to neurogenic lung injury. Up to this day, little is known whether the extent of brain damage in patients with SAH correlates with the degree of neurogenic myocardial injury. Moreover, it remains unknown what is the full clinical picture and duration of this type of myocardial injury and how often it co-occurs with neurogenic lung injury. Such analysis is a fundamental and most important step in optimising the treatment of these patients.
Methods: In this prospective observational study the authors aim to recruit 30 patients with subarachnoid haemorrhage, requiring hospitalization in the Intensive Care Unit. The patients will be monitored for elevation in cardiac damage markers (hs-TnT, CPK, CK-MB, NT-proBNP) and worsening of respiratory conditions, defined by need for more invasive ventilation parameters, and subsequent changes in arterial blood gas. The above mentioned parameters will be assessed every 12 hours. Additionally, the patients will be screened for an elevation in catecholamine metabolite (metanephrine) concentration in 12-hour urine collection.
Hypothesis to be tested: Myocardial and lung injury in SAH patients is timely-associated with an increase in metanephrine concentration in urine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with subarachnoid haemorrhage | – | Diagnostic Test: hs-TnT (high-sensitive cardiac troponin T) plasma concentration, Diagnostic Test: CK-MB (creatine kinase myocardial band) plasma concentration, Diagnostic Test: CPK (creatine phosphokinase) plasma concentration, Diagnostic Test: NT-proBNP (N-terminal prohormone of brain natriuretic peptide) plasma concentration, Diagnostic Test: Metanephrine concentration in urinePatients aged 18 or older hospitalized in the Intensive Care Unit with Subarachnoid Haemorrhage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with subarachnoid haemorrhage admitted to the Intensive Care Unit.
Key inclusion criteria (1 listed)
- patients with subarachnoid haemorrhage (both aneurysmal and non-aneurysmal) with acute consciousness disturbances (Glasgow Coma Scale < 8 pts) requiring intubation and mechanical ventilation, hospitalized in the ICU for over 24 hours
Key exclusion criteria (4 listed)
- severe prior pulmonary diseases
- severe prior cardiac diseases
- death in the first 72 hours of ICU stay
- need for any extracorporeal life-saving techniques
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 |
|---|---|---|
| hs-TnT (high-sensitive cardiac troponin T) plasma concentrationhs-TnT plasma concentration measured once every 12 hours | Diagnostic test | Patients with subarachnoid haemorrhage |
| CK-MB (creatine kinase myocardial band) plasma concentrationCK-MB plasma concentration measured every 12 hours | Diagnostic test | Patients with subarachnoid haemorrhage |
| CPK (creatine phosphokinase) plasma concentrationCPK plasma concentration measured every 12 hours | Diagnostic test | Patients with subarachnoid haemorrhage |
| NT-proBNP (N-terminal prohormone of brain natriuretic peptide) plasma concentrationNT-proBNP plasma concentration measured every 12 hours | Diagnostic test | Patients with subarachnoid haemorrhage |
| Metanephrine concentration in urineMetanephrine concentration measured in 12-hour urine collection using spectrophotometry. | Diagnostic test | Patients with subarachnoid haemorrhage |
Primary outcome
In-hospital death (number of patients)
Time frame: 7 days
Death of the patient during the first 7 days of hospitalization.
Number of Patients with elevation in hs-TnT levels
Time frame: 7 days
hs-TnT treated as myocardial injury biomarker
Number of Patients with elevation in NT-proBNP levels
Time frame: 7 days
NT-proBNP treated as myocardial injury biomarker
Number of Patients with elevation in creatine kinase levels
Time frame: 7 days
Creatine kinase treated as myocardial injury biomarker
Number of Patients with elevation in creatine kinase MB levels
Time frame: 7 days
Creatine kinase MB treated as myocardial injury biomarker
Number of Patients with a decrease in Horowitz index
Time frame: 7 days
The decrease in Horowitz index treated as a sign of need for more invasive ventilation parameters with subsequent blood gas changes
Number of Patients with need of increased FiO2
Time frame: 7 days
Need of increased FiO2 treated as a sign of need for more invasive ventilation parameters with subsequent blood gas changes
Number of Patients with need of increased PEEP values
Time frame: 7 days
Need of increased PEEP values treated as a sign of need for more invasive ventilation parameters with subsequent blood gas changes
Number of Patients with need for the use of neuro-muscular blocking agents
Time frame: 7 days
Need for the use of neuro-muscular blocking agents treated as a sign of need for more invasive ventilation parameters with subsequent blood gas changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 34308493Osgood ML. Aneurysmal Subarachnoid Hemorrhage: Review of the Pathophysiology and Management Strategies. Curr Neurol Neurosci Rep. 2021 Jul 26;21(9):50. doi: 10.1007/s11910-021-01136-9.
- Background: PubMed 32545225Hofman M, Hajder N, Duda I, Krzych LJ. A Questionnaire Survey of Management of Patients with Aneurysmal Subarachnoid Haemorrhage in Poland. Int J Environ Res Public Health. 2020 Jun 11;17(11):4161. doi: 10.3390/ijerph17114161.
- Background: PubMed 24526502Wybraniec MT, Mizia-Stec K, Krzych L. Neurocardiogenic injury in subarachnoid hemorrhage: A wide spectrum of catecholamin-mediated brain-heart interactions. Cardiol J. 2014;21(3):220-8. doi: 10.5603/CJ.a2014.0019. Epub 2014 Feb 14.
- Background: PubMed 24462197Wybraniec M, Mizia-Stec K, Krzych L. Stress cardiomyopathy: yet another type of neurocardiogenic injury: 'stress cardiomyopathy'. Cardiovasc Pathol. 2014 May-Jun;23(3):113-20. doi: 10.1016/j.carpath.2013.12.003. Epub 2013 Dec 27.
- Background: PubMed 24560705Veeravagu A, Chen YR, Ludwig C, Rincon F, Maltenfort M, Jallo J, Choudhri O, Steinberg GK, Ratliff JK. Acute lung injury in patients with subarachnoid hemorrhage: a nationwide inpatient sample study. World Neurosurg. 2014 Jul-Aug;82(1-2):e235-41. doi: 10.1016/j.wneu.2014.02.030. Epub 2014 Feb 20.
- Background: PubMed 33083966Mazeraud A, Robba C, Rebora P, Iaquaniello C, Vargiolu A, Rass V, Bogossian EG, Helbok R, Taccone FS, Citerio G. Acute Distress Respiratory Syndrome After Subarachnoid Hemorrhage: Incidence and Impact on the Outcome in a Large Multicenter, Retrospective Cohort. Neurocrit Care. 2021 Jun;34(3):1000-1008. doi: 10.1007/s12028-020-01115-x. Epub 2020 Oct 20.
- Background: PubMed 34373566Anetsberger A, Jungwirth B, Blobner M, Ringel F, Bernlochner I, Heim M, Bogdanski R, Wostrack M, Schneider G, Meyer B, Graessner M, Baumgart L, Gempt J. Association of Troponin T levels and functional outcome 3 months after subarachnoid hemorrhage. Sci Rep. 2021 Aug 9;11(1):16154. doi: 10.1038/s41598-021-95717-w.
- 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.
Łukasz Krzych, PhD study chair
University Clinical Center prof. K. Gibiński of the Medical University of Silesia in Katowice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Injury and Lung Injury, run by Medical University of Silesia at 1 site in Poland.
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 1 inclusion and 4 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 Natalia Rachfalska (+48 32 789 42 01, n.rachfalska@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital death (number of patients) (time frame: 7 days). The study lists 9 primary outcomes in all. 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 NCT05408988, which also lists 7 linked publications.
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 6 May 2023.