Cardiac Arrest, Out-Of-HospitalNCT05830422
Prediction of Delayed Cognitive Impairment in Cardiac Arrest Survivors With Good Neurological Outcomes
An observational study of Cardiac Arrest, Out-Of-Hospital and Cognitive Impairment, run by Chungnam National University Hospital at 1 site in South Korea.
Trial summary
The objective of this observational study is to provide basic data for predicting and analyzing the occurrence and causes of delayed cognitive impairment, an important factor in the quality of life, among discharged patients who have received targeted temperature management therapy and experienced favorable… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Out-Of-Hospital, Cognitive Impairment
- What is being tested?
- nothing
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2023to 30 Sep 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: For subjects who survived after out-of-hospital cardiac arrest, the prognosis was evaluated 10-14 days after ROSC using CPC. For CPC 1-2, neurological prognosis was evaluated as good, and for CPC 3-5, neurological prognosis was evaluated as poor. Only cases of CPC 1-2 between 10 and 14 days after ROSC were included in this study.
Who may be able to join
- Patients who visited the hospital emergency room due to cardiac arrest within 60 months after Institutional Review Board (IRB) approval
- Patients with Glasgow Coma Scale (GCS) less than 8 points after spontaneous circulation recovery
- Patients who are 18 years old or older
- Patients who underwent targeted temperature management (TTM)
- Patients who showed good neurological outcomes with CPC 1-2 points after evaluating the prognosis on days 10-14 after ROSC
Who cannot join
- Under 18 years of age
- cardiac arrest cause is trauma
- Patients who have not undergone targeted temperature management
- Patients treated with extracorporeal membrane oxygenation (ECMO)
- Patients who were not able to undergo SNSB testing
- Patients who could not be followed up until 6 months after ROSC
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The objective of this observational study is to provide basic data for predicting and analyzing the occurrence and causes of delayed cognitive impairment, an important factor in the quality of life, among discharged patients who have received targeted temperature management therapy and experienced favorable neurological outcomes after out-of-hospital cardiac arrest.
The main questions it aims to answer are:
- Can we identify abnormal areas in the brains of patients with delayed cognitive impairment using Brain MRI or positron emission tomography (PET) imaging?
- Is it possible to predict delayed cognitive impairment using biomarkers?
Read the detailed description
- For study subjects who survived after out-of-hospital cardiac arrest, prognosis was evaluated using Cerebral Performance Category (CPC) scores on days 10-14 after return of spontaneous circulation (ROSC). A CPC score of 1-2 indicates a good neurological prognosis, while a score of 3-5 indicates a poor neurological prognosis. Only subjects with CPC scores of 1-2 were included in this study.
- Blood samples were collected through venous puncture at days 10-14, 3 months, and 6 months after ROSC, and the obtained blood was drawn into an serum separating tube (SST) bottle without anticoagulants, then centrifuged within 60 minutes after collection (at 3,000rpm for at least 10 minutes) and divided into tubes. The processed tubes were stored at -70°C.
- The storage period of the samples is 5 years from the date of collection, and they are stored in a coded manner for anonymization.
- The Human Neurology 4-ples A 2.0 Assay Kit (including neurofilament light chain, Tau protein, ubiquitin carboxyl terminal esterase L1 protein [UCHL1], and glial fibrillary acidic protein antibody) was analyzed using the single molecule protein detection (SIMOA) analysis machine, and neuron-specific enolase (NSE) in the blood was analyzed together as a reference point to assess the usefulness of each biomarker.
- Through the Seoul Neuropsychological Screening Battery (SNSB), attention, language and related functions, visuospatial function, memory, frontal lobe and executive function, and other related functions can be assessed. The test is conducted by a specialist clinical psychologist for 1 hour and 30 minutes to 2 hours, and the results are analyzed by Professor Oh Eung-Seok, a neurologist. The presence of cognitive impairment is assessed by conducting tests at 10-14 days, 3 months, and 6 months after ROSC for out-of-hospital cardiac arrest patients with CPC 1-2 points who have passed 10-14 days since ROSC. In addition, through detailed item analysis of the SNSB, functional abnormalities and affected areas (such as the frontal lobe, parietal lobe, temporal lobe, and occipital lobe) are analyzed.
- We consulted with the departments of radiology, nuclear medicine, and neurology professors to establish the optimal fluorine-18 (18F) fluorodeoxyglucose (FDG) PET \& MRI examination protocol. The first MRI examination was performed 72-96 hours after ROSC, as recommended by international treatment guidelines for predicting neurological prognosis. The first [18F]-FDG PET examination was performed at 10-14 days after ROSC, as it may result in false positives if performed too early in cardiac arrest patients. A minimum of 10 days is recommended before performing the examination. If cognitive impairment is observed in the SNSB examination at 3 months after ROSC, a second [18F]-FDG PET \& MRI examination is performed. If the cognitive function is normal at 6 months, the examination is performed regardless of cognitive impairment.
- Prediction and analysis of delayed cognitive impairment and cause analysis in out-of-hospital cardiac arrest patients with good neurological outcomes
- Delayed cognitive impairment is defined based on the SNSB results, and is defined as the positive group. For biomarkers, differences between the positive and negative groups are determined at each time point, and the predictive power and cut-off values are determined using area under the receiver operating characteristics curve. For images, the functional or anatomical differences between the two groups are compared.
- Predictive power analysis Through SNSB, the patient's cognitive impairment and the time point of recognition are measured, and the level of biomarkers tested prior to the recognition of impairment is checked to analyze the predictive power. Therefore, the time points for predictive power analysis are 10-14 days, 3 months, and 6 months after ROSC. The first and second [18F]-FDG PET \& MRI findings are analyzed to identify differences between the cognitive impairment group and the normal group. Using multiple modes combining clinical data, biomarkers, [18F]-FDG PET, MRI, etc., a predictive model for delayed cognitive impairment is developed.
- Cause analysis Investigate the impairment findings and location using the continuously measured SNSB test values. Analyze the first and second [18F]-FDG PET and MRI findings to investigate the functional or anatomical abnormalities occurring in patients with cognitive impairment.
- Being tested
- nothing
- Keywords
- cardiac arrest, outcome, cognition impairment, magnetic resonance imaging, Positron emission tomography
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Cognitive Dysfunction, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nothingOther
Follow-up observation was conducted without any intervention in an outpatient setting.
| Study group | Role | What they receive |
|---|---|---|
| Good neurological outcome | Patients who showed good neurological outcomes with CPC scores of 1-2 at discharge Receives: Other: nothing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive impairment
Through the Seoul Neuropsychological Screening Battery (SNSB), attention, language and related functions, visuospatial function, memory, frontal lobe and executive function, and other related functions can be assessed. The test is conducted by a specialist clinical psychologist for 1 hour and 30 minutes to 2 hours, and the results are analyzed by Professor Oh Eung-Seok, a neurologist.
Measured: at 10-14 days, 3 months, and 6 months after return of spontaneous circulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Nov 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest, Out-Of-HospitalStudies 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
- 40 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Chungnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung Soo Park, MD.Phd, Study chair, (35015) Chungnam National University Hospital, 282 Munhwa-ro, Jung-gu, Daejeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830422
- Sponsor's protocol ID
- CNUH 2022-10-059-004
- Status last verified
- Mar 2023
- First submitted
- 29 Mar 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to make individual participant data (IPD) available to other researchers.
Publications
Cronberg T, Greer DM, Lilja G, Moulaert V, Swindell P, Rossetti AO. Brain injury after cardiac arrest: from prognostication of comatose patients to rehabilitation. Lancet Neurol. 2020 Jul;19(7):611-622. doi: 10.1016/S1474-4422(20)30117-4.
PubMed 32562686Bronnick K, Evald L, Duez CHV, Grejs AM, Jeppesen AN, Kirkegaard H, Nielsen JF, Soreide E. Biomarker prognostication of cognitive impairment may be feasible even in out-of hospital cardical arrest survivors with good neurological outcome. Resuscitation. 2021 May;162:396-402. doi: 10.1016/j.resuscitation.2021.02.025. Epub 2021 Feb 22.
PubMed 33631291Moulaert VR, Verbunt JA, van Heugten CM, Wade DT. Cognitive impairments in survivors of out-of-hospital cardiac arrest: a systematic review. Resuscitation. 2009 Mar;80(3):297-305. doi: 10.1016/j.resuscitation.2008.10.034. Epub 2008 Dec 30.
PubMed 19117659Elliott VJ, Rodgers DL, Brett SJ. Systematic review of quality of life and other patient-centred outcomes after cardiac arrest survival. Resuscitation. 2011 Mar;82(3):247-56. doi: 10.1016/j.resuscitation.2010.10.030. Epub 2011 Jan 8.
PubMed 21216080
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Delayed Cognitive Impairment in Cardiac Arrest Survivors With Good Neurological Outcomes
- ClinicalTrials.gov ID
- NCT05830422
- Acronym / sponsor ID
- CNUH 2022-10-059-004
- Keywords
- cardiac arrest, outcome, cognition impairment, magnetic resonance imaging, Positron emission tomography
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chungnam National University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 26 Apr 2023 (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 objective of this observational study is to provide basic data for predicting and analyzing the occurrence and causes of delayed cognitive impairment, an important factor in the quality of life, among discharged patients who have received targeted temperature management therapy and experienced favorable neurological outcomes after out-of-hospital cardiac arrest.
The main questions it aims to answer are:
- Can we identify abnormal areas in the brains of patients with delayed cognitive impairment using Brain MRI or positron emission tomography (PET) imaging?
- Is it possible to predict delayed cognitive impairment using biomarkers?
Detailed description
- For study subjects who survived after out-of-hospital cardiac arrest, prognosis was evaluated using Cerebral Performance Category (CPC) scores on days 10-14 after return of spontaneous circulation (ROSC). A CPC score of 1-2 indicates a good neurological prognosis, while a score of 3-5 indicates a poor neurological prognosis. Only subjects with CPC scores of 1-2 were included in this study.
- Blood samples were collected through venous puncture at days 10-14, 3 months, and 6 months after ROSC, and the obtained blood was drawn into an serum separating tube (SST) bottle without anticoagulants, then centrifuged within 60 minutes after collection (at 3,000rpm for at least 10 minutes) and divided into tubes. The processed tubes were stored at -70°C.
- The storage period of the samples is 5 years from the date of collection, and they are stored in a coded manner for anonymization.
- The Human Neurology 4-ples A 2.0 Assay Kit (including neurofilament light chain, Tau protein, ubiquitin carboxyl terminal esterase L1 protein [UCHL1], and glial fibrillary acidic protein antibody) was analyzed using the single molecule protein detection (SIMOA) analysis machine, and neuron-specific enolase (NSE) in the blood was analyzed together as a reference point to assess the usefulness of each biomarker.
- Through the Seoul Neuropsychological Screening Battery (SNSB), attention, language and related functions, visuospatial function, memory, frontal lobe and executive function, and other related functions can be assessed. The test is conducted by a specialist clinical psychologist for 1 hour and 30 minutes to 2 hours, and the results are analyzed by Professor Oh Eung-Seok, a neurologist. The presence of cognitive impairment is assessed by conducting tests at 10-14 days, 3 months, and 6 months after ROSC for out-of-hospital cardiac arrest patients with CPC 1-2 points who have passed 10-14 days since ROSC. In addition, through detailed item analysis of the SNSB, functional abnormalities and affected areas (such as the frontal lobe, parietal lobe, temporal lobe, and occipital lobe) are analyzed.
- We consulted with the departments of radiology, nuclear medicine, and neurology professors to establish the optimal fluorine-18 (18F) fluorodeoxyglucose (FDG) PET \& MRI examination protocol. The first MRI examination was performed 72-96 hours after ROSC, as recommended by international treatment guidelines for predicting neurological prognosis. The first [18F]-FDG PET examination was performed at 10-14 days after ROSC, as it may result in false positives if performed too early in cardiac arrest patients. A minimum of 10 days is recommended before performing the examination. If cognitive impairment is observed in the SNSB examination at 3 months after ROSC, a second [18F]-FDG PET \& MRI examination is performed. If the cognitive function is normal at 6 months, the examination is performed regardless of cognitive impairment.
- Prediction and analysis of delayed cognitive impairment and cause analysis in out-of-hospital cardiac arrest patients with good neurological outcomes
- Delayed cognitive impairment is defined based on the SNSB results, and is defined as the positive group. For biomarkers, differences between the positive and negative groups are determined at each time point, and the predictive power and cut-off values are determined using area under the receiver operating characteristics curve. For images, the functional or anatomical differences between the two groups are compared.
- Predictive power analysis Through SNSB, the patient's cognitive impairment and the time point of recognition are measured, and the level of biomarkers tested prior to the recognition of impairment is checked to analyze the predictive power. Therefore, the time points for predictive power analysis are 10-14 days, 3 months, and 6 months after ROSC. The first and second [18F]-FDG PET \& MRI findings are analyzed to identify differences between the cognitive impairment group and the normal group. Using multiple modes combining clinical data, biomarkers, [18F]-FDG PET, MRI, etc., a predictive model for delayed cognitive impairment is developed.
- Cause analysis Investigate the impairment findings and location using the continuously measured SNSB test values. Analyze the first and second [18F]-FDG PET and MRI findings to investigate the functional or anatomical abnormalities occurring in patients with cognitive impairment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Good neurological outcome | – | Other: nothingPatients who showed good neurological outcomes with CPC scores of 1-2 at discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For subjects who survived after out-of-hospital cardiac arrest, the prognosis was evaluated 10-14 days after ROSC using CPC. For CPC 1-2, neurological prognosis was evaluated as good, and for CPC 3-5, neurological prognosis was evaluated as poor. Only cases of CPC 1-2 between 10 and 14 days after ROSC were included in this study.
Key inclusion criteria (5 listed)
- Patients who visited the hospital emergency room due to cardiac arrest within 60 months after Institutional Review Board (IRB) approval
- Patients with Glasgow Coma Scale (GCS) less than 8 points after spontaneous circulation recovery
- Patients who are 18 years old or older
- Patients who underwent targeted temperature management (TTM)
- Patients who showed good neurological outcomes with CPC 1-2 points after evaluating the prognosis on days 10-14 after ROSC
Key exclusion criteria (6 listed)
- Under 18 years of age
- cardiac arrest cause is trauma
- Patients who have not undergone targeted temperature management
- Patients treated with extracorporeal membrane oxygenation (ECMO)
- Patients who were not able to undergo SNSB testing
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 |
|---|---|---|
| nothingFollow-up observation was conducted without any intervention in an outpatient setting. | Other | Good neurological outcome |
Primary outcome
Change in cognitive impairment
Time frame: at 10-14 days, 3 months, and 6 months after return of spontaneous circulation
Through the Seoul Neuropsychological Screening Battery (SNSB), attention, language and related functions, visuospatial function, memory, frontal lobe and executive function, and other related functions can be assessed. The test is conducted by a specialist clinical psychologist for 1 hour and 30 minutes to 2 hours, and the results are analyzed by Professor Oh Eung-Seok, a neurologist.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Results publication: PubMed 32562686Cronberg T, Greer DM, Lilja G, Moulaert V, Swindell P, Rossetti AO. Brain injury after cardiac arrest: from prognostication of comatose patients to rehabilitation. Lancet Neurol. 2020 Jul;19(7):611-622. doi: 10.1016/S1474-4422(20)30117-4.
- Results publication: PubMed 33631291Bronnick K, Evald L, Duez CHV, Grejs AM, Jeppesen AN, Kirkegaard H, Nielsen JF, Soreide E. Biomarker prognostication of cognitive impairment may be feasible even in out-of hospital cardical arrest survivors with good neurological outcome. Resuscitation. 2021 May;162:396-402. doi: 10.1016/j.resuscitation.2021.02.025. Epub 2021 Feb 22.
- Results publication: PubMed 19117659Moulaert VR, Verbunt JA, van Heugten CM, Wade DT. Cognitive impairments in survivors of out-of-hospital cardiac arrest: a systematic review. Resuscitation. 2009 Mar;80(3):297-305. doi: 10.1016/j.resuscitation.2008.10.034. Epub 2008 Dec 30.
- Results publication: PubMed 21216080Elliott VJ, Rodgers DL, Brett SJ. Systematic review of quality of life and other patient-centred outcomes after cardiac arrest survival. Resuscitation. 2011 Mar;82(3):247-56. doi: 10.1016/j.resuscitation.2010.10.030. Epub 2011 Jan 8.
- Individual participant dataSharing planned: No. There are no plans to make individual participant data (IPD) available to other researchers.
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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.
Jung Soo Park, MD.Phd study chair
(35015) Chungnam National University Hospital, 282 Munhwa-ro, Jung-gu, Daejeon
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 Cardiac Arrest, Out-Of-Hospital and Cognitive Impairment, run by Chungnam National University Hospital at 1 site in South Korea.
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 5 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 9 Feb 2024. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive impairment (time frame: at 10-14 days, 3 months, and 6 months after return of spontaneous circulation). 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 NCT05830422, which also lists 4 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 9 Feb 2024.