Neuropsychological Outcome After Cardiac Arrest (NCT03543371) | Clinical Trial Compass
CompletedNot Applicable
Neuropsychological Outcome After Cardiac Arrest
Denmark, Sweden, United Kingdom200 participantsStarted 2018-07-13
Plain-language summary
This study is a sub-study to the large pragmatic Target Temperature Management 2 Trial (TTM2-trial, ClinicalTrials.gov Identifier: NCT02908308), assessing effectiveness of controlled hypothermia after out-of-hospital cardiac arrest (OHCA).
This study is designed to provide detailed information on cognition after OHCA and its relationship to associated factors as emotional function, fatigue, and sleep. A secondary aim is to utilize this information to validate a neurocognitive screening battery used 6 months after OHCA in the TTM2-trial.
Approximately 7 and 24 months after OHCA, survivors at selected TTM2 study sites will perform a standardized neuropsychological assessment including performance-based tests of cognition and questionnaires of behavioral and emotional function, fatigue, and insomnia. At 1:1 ratio, a control group of myocardial infarction (MI) patients but no occurrence of cardiac arrest will be recruited and perform the same test battery. Group differences at 7 and 24 months will be analyzed per cognitive domain (verbal, visual/constructive, short-term working memory, episodic memory, processing speed, executive functions). Results of the OHCA survivors on the TTM2 neurocognitive screening battery will be compared with neuropsychological test results at 7 months time.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* OHCA of a presumed cardiac or unknown cause (OHCA cohort only)
* Sustained return of spontaneous circulation (ROSC) during intensive care - defined as 20 minutes with signs of circulation without the need for chest compressions (OHCA cohort only)
* Unconsciousness - defined as not being able to obey verbal commands (FOUR-score motor response of \<4) and no verbal response to pain after sustained ROSC (OHCA cohort only)
* Inclusion within 180 minutes of ROSC (OHCA cohort only)
* During intensive care - eligible for intensive care without restrictions or limitations (OHCA cohort only)
* MI with performed coronary angiography (MI cohort only)
Exclusion Criteria:
* Temperature on admission \<30°C (OHCA cohort only)
* On extracorporeal membrane oxygenation (ECMO) prior to return of spontaneous circulation (OHCA cohort only)
* Obvious or suspected pregnancy
* Intracranial bleeding (OHCA cohort only)
* Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy
* Clinical dementia diagnosis before the event
* Inability to speak the local language well enough to complete the assessment without assistance from an interpreter
* Inability to meet for a face-to-face examination
* Clinical Frailty Scale Index ≥8, indicating very severe frailty
* Cardiac arrest before or in connection with MI (MI cohort only)
* Active substance abuse
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.