Cardiac ArrestTIMECARDNCT03578328
TaIwan Network of Targeted Temperature ManagEment for CARDiac Arrest Registry (TIMECARD)
An observational study of Cardiac Arrest and Targeted Temperature Management, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goals of the study are to establish the study cohort and database for out-of-hospital cardiac arrest patients. Indications and factors influencing the application of hypothermia treatment on cardiac arrest patients will be analyzed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Targeted Temperature Management, Registry
- What is being tested?
- targeted temperature management
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2018to Aug 2021
- 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: Adult, non-traumatic, in- or out-of-hospital cardiac arrest patients after cardiopulmonary resuscitation with return of spontaneous circulation. Comatose, defined as Glasgow Coma Score (motor+eye) < 8 or cannot obey verbal command Receiving targeted temperature management within 12 hours after return of spontaneous circulation
Who may be able to join
- Age ≧18
- Non-traumatic cardiac arrest
- in- or out-of-hospital cardiac arrest requiring cardiopulmonary resuscitation
- Comatose, defined as Glasgow Coma Score (motor+eye) < 8 or cannot obey verbal command
- Within 12 hours of return of spontaneous circulation
Who cannot join
- nil
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Chien-Hua Huang, MD, PhD, chhuang730@gmail.com
About this study
Official title: TaIwan Network of Targeted Temperature ManagEment for CARDiac Arrest Registry
The goals of the study are to establish the study cohort and database for out-of-hospital cardiac arrest patients. Indications and factors influencing the application of hypothermia treatment on cardiac arrest patients will be analyzed. The prognostic evaluation modalities under hypothermia treatment will be evaluated for their accuracy and optimal time points. These finding and results could be applied in clinical practice in the future.
Read the detailed description
The importance of cardiopulmonary resuscitation has been emphasized in recent years. The chance of return of spontaneous circulation improves up to 70%. However, only 20 % of cardiac arrest patients can survive to hospital discharge because of post-cardiac arrest syndrome due to global ischemia-reperfusion injuries in cardiac arrest and resuscitation. Although there are some studies trying to predict the survival outcomes in cardiac arrest, the prediction variables are limited to the pre-arrest variables such as age, pre-morbidities. The impact of these variables on long term outcomes is neither clear nor well-defined. It is found that the chances of survival to discharge are significant different among different hospitals and districts. It implies that the intensive managements and treatment policies could influence the outcomes in cardiac arrest patients. However, the critical procedures or managements have not been systemically studied and remain undefined. Targeted temperature management based on hypothermia treatment changes the post-cardiac arrest care and improves the outcome in cardiac arrest patients. Under hypothermia treatment, the critical time points of evaluating prognosis are changed because of 24 hours maintaining cooling period and 12-18 hours rewarming period. The full neurological recovery cannot be evaluated at 24 hours after return of spontaneous circulation as the suggestion in old days without hypothermia treatment. The optimal time points for evaluating and predicting long term outcomes need to be re-defined. The accuracy of different modalities for outcome prediction also needed to be re-evaluated in the hypothermia treatment era. Early and precise prediction of good recovery and favorable outcomes are very important in determining the further intensive treatment strategies by physicians and family for cardiac arrest patients.
The goals of the study are to establish the study cohort and database for out-of-hospital cardiac arrest patients. Indications and factors influencing the application of hypothermia treatment on cardiac arrest patients will be analyzed. The prognostic evaluation modalities under hypothermia treatment will be evaluated for their accuracy and optimal time points. These finding and results could be applied in clinical practice in the future.
- Conditions
- Cardiac Arrest, Targeted Temperature Management, Registry
- Being tested
- targeted temperature management
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
targeted temperature managementProcedure or surgery
Temperature control to targeted temperature (32-36C) after return of spontaneous circulation after cardiac arrest and resuscitation
| Study group | Role | What they receive |
|---|---|---|
| Cardiac arrest with targeted temperature management | Not described Receives: Procedure: targeted temperature management |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
Measured: within one year
favorable neurological outcome when hospital discharge
Cerebral Performance Category less than 3
Measured: within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Jun 2018
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (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 Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University Shuang Ho Hospital, Mackay Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Taichung Veterans General Hospital, Kaohsiung Veterans General Hospital., Changhua Christian Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Far Eastern Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Chien-Hua Huang, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578328
- Sponsor's protocol ID
- 201708013RIND
- Acronym
- TIMECARD
- Status last verified
- Jul 2019
- First submitted
- 12 Jun 2018
- Last updated
- 23 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing
Publications
Chang HC, Tsai MS, Kuo LK, Hsu HH, Huang WC, Lai CH, Huang CH. Analysis of possible factors affecting neurologic outcomes of resuscitated cardiac arrest patients with initial non-shockable rhythm after targeted temperature management. J Formos Med Assoc. 2026 Mar;125(3):320-327. doi: 10.1016/j.jfma.2025.03.025. Epub 2025 Apr 2.
PubMed 40180874
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TaIwan Network of Targeted Temperature ManagEment for CARDiac Arrest Registry
- ClinicalTrials.gov ID
- NCT03578328
- Acronym / sponsor ID
- TIMECARD / 201708013RIND
- Conditions
- Cardiac Arrest, Targeted Temperature Management, Registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University Shuang Ho Hospital, Mackay Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Taichung Veterans General Hospital, Kaohsiung Veterans General Hospital., Changhua Christian Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Far Eastern Memorial Hospital
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 6 Jul 2018 (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 goals of the study are to establish the study cohort and database for out-of-hospital cardiac arrest patients. Indications and factors influencing the application of hypothermia treatment on cardiac arrest patients will be analyzed. The prognostic evaluation modalities under hypothermia treatment will be evaluated for their accuracy and optimal time points. These finding and results could be applied in clinical practice in the future.
Detailed description
The importance of cardiopulmonary resuscitation has been emphasized in recent years. The chance of return of spontaneous circulation improves up to 70%. However, only 20 % of cardiac arrest patients can survive to hospital discharge because of post-cardiac arrest syndrome due to global ischemia-reperfusion injuries in cardiac arrest and resuscitation. Although there are some studies trying to predict the survival outcomes in cardiac arrest, the prediction variables are limited to the pre-arrest variables such as age, pre-morbidities. The impact of these variables on long term outcomes is neither clear nor well-defined. It is found that the chances of survival to discharge are significant different among different hospitals and districts. It implies that the intensive managements and treatment policies could influence the outcomes in cardiac arrest patients. However, the critical procedures or managements have not been systemically studied and remain undefined. Targeted temperature management based on hypothermia treatment changes the post-cardiac arrest care and improves the outcome in cardiac arrest patients. Under hypothermia treatment, the critical time points of evaluating prognosis are changed because of 24 hours maintaining cooling period and 12-18 hours rewarming period. The full neurological recovery cannot be evaluated at 24 hours after return of spontaneous circulation as the suggestion in old days without hypothermia treatment. The optimal time points for evaluating and predicting long term outcomes need to be re-defined. The accuracy of different modalities for outcome prediction also needed to be re-evaluated in the hypothermia treatment era. Early and precise prediction of good recovery and favorable outcomes are very important in determining the further intensive treatment strategies by physicians and family for cardiac arrest patients.
The goals of the study are to establish the study cohort and database for out-of-hospital cardiac arrest patients. Indications and factors influencing the application of hypothermia treatment on cardiac arrest patients will be analyzed. The prognostic evaluation modalities under hypothermia treatment will be evaluated for their accuracy and optimal time points. These finding and results could be applied in clinical practice in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac arrest with targeted temperature management | – | Procedure: targeted temperature management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, non-traumatic, in- or out-of-hospital cardiac arrest patients after cardiopulmonary resuscitation with return of spontaneous circulation. Comatose, defined as Glasgow Coma Score (motor+eye) < 8 or cannot obey verbal command Receiving targeted temperature management within 12 hours after return of spontaneous circulation
Key inclusion criteria (5 listed)
- Age ≧18
- Non-traumatic cardiac arrest
- in- or out-of-hospital cardiac arrest requiring cardiopulmonary resuscitation
- Comatose, defined as Glasgow Coma Score (motor+eye) < 8 or cannot obey verbal command
- Within 12 hours of return of spontaneous circulation
Key exclusion criteria (1 listed)
- nil
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 |
|---|---|---|
| targeted temperature managementTemperature control to targeted temperature (32-36C) after return of spontaneous circulation after cardiac arrest and resuscitation | Procedure or surgery | Cardiac arrest with targeted temperature management |
Primary outcome
in-hospital mortality
Time frame: within one year
favorable neurological outcome when hospital discharge
Time frame: within one year
Cerebral Performance Category less than 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Derived from this study: PubMed 40180874Chang HC, Tsai MS, Kuo LK, Hsu HH, Huang WC, Lai CH, Huang CH. Analysis of possible factors affecting neurologic outcomes of resuscitated cardiac arrest patients with initial non-shockable rhythm after targeted temperature management. J Formos Med Assoc. 2026 Mar;125(3):320-327. doi: 10.1016/j.jfma.2025.03.025. Epub 2025 Apr 2.
- Individual participant dataSharing planned: No. No sharing
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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.
Chien-Hua Huang principal investigator
National Taiwan University Hospital
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 and Targeted Temperature Management, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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 23 Jun 2020. 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 Taiwan. 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 Chien-Hua Huang, MD, PhD (886-2-23562831, chhuang730@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospital mortality (time frame: within one year). The study lists 2 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 NCT03578328, 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 23 Jun 2020.