Prediction of Delayed Cognitive Impairment in Cardiac Arrest Survivors With Good Neurological Outcomes

NCT05830422 | Enrolling By Invitation DMC

• 1 other identifier: CNUH 2022-10-059-004
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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?

Conditions

Cardiac Arrest, Out-Of-Hospital; Cognitive Impairment

Keywords

cardiac arrest; outcome; cognition impairment; magnetic resonance imaging; Positron emission tomography

Outcome Measures

Primary Outcomes (1)

• 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.

  at 10-14 days, 3 months, and 6 months after return of spontaneous circulation

Study Arms (1)

Good neurological outcome

Patients who showed good neurological outcomes with CPC scores of 1-2 at discharge

Other: nothing

Interventions

nothing OTHER

Follow-up observation was conducted without any intervention in an outpatient setting.

Good neurological outcome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chungnam National University Hospital: lead

Study Sites (1)

박정수

Daejeon, Seo-gu, 35248, South Korea

Location

Related Publications (4)

• 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.

  PMID: 32562686 RESULT

• Bronnick 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.

  PMID: 33631291 RESULT

• Moulaert 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.

  PMID: 19117659 RESULT

• Elliott 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.

  PMID: 21216080 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood was collected 10-14 days, 3 months, and 6 months after ROSC by venipuncture, and the obtained blood was collected in an SST bottle without anticoagulant and centrifuged (3,000 rpm, 10 minutes or more) within 60 minutes. Divided into tubes, and pre-treated tubes are stored frozen at -70 degrees.

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Cognitive Dysfunction; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jung Soo Park, MD.Phd

  (35015) Chungnam National University Hospital, 282 Munhwa-ro, Jung-gu, Daejeon

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 26, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: February 9, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)