Post-Cardiac Arrest SyndromeNCT04859270
The Holistic Health Care of Post-Cardiac Arrest Survivors: From Patient's Health to Family Resilience
An observational study of Post-Cardiac Arrest Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Post-cardiac arrest mortality remains high and proper care after cardiopulmonary resuscitation is an important clinical challenge. This prospective observational cohort aims to (1) identify the factors that affect short-term and long-term survival in post-cardiac arrest survivors and (2) investigate the patients and… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Post-Cardiac Arrest Syndrome
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Apr 2021to 31 Mar 2027
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The primary participants of the study are patients with out-of-hospital cardiac arrest and achieved return of spontaneous circulation after cardiopulmonary resuscitation. The number of primary participants is 200, and the interviewees are patients and their family members (400), a total of 600 participants.
Who may be able to join
- 1. Patients with non-traumatic cardiac arrest, who have successfully sustained return of spontaneous circulation for more than five minutes after resuscitation efforts.
Who cannot join
- Under 20 years of age
- Pregnant
- Terminally ill cancer patients or cancer patients who are unwilling to receive treatment
- When the ICU is over capacity and unable to provide intensive care.
- The patient or family members refused to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chien-Hua Huang
About this study
Post-cardiac arrest mortality remains high and proper care after cardiopulmonary resuscitation is an important clinical challenge. This prospective observational cohort aims to (1) identify the factors that affect short-term and long-term survival in post-cardiac arrest survivors and (2) investigate the patients and their families' health-related quality of life and psychological well-being.
Read the detailed description
For this cohort study, adult survivors (≧20 years) of sudden cardiac arrest for more than 5 minutes after cardiopulmonary resuscitation will be enrolled. Basic demographic information, clinical events throughout hospitalization, and laboratory examination results will be recorded. Patients will be assessed for their neurological outcome using Glasgow coma score (GCS) and cerebral performance categories (CPC) upon hospital discharge, 1, 3, 6, and 12 months after discharge.
Post-cardiac arrest care is clinically challenging and this study aims to evaluate not just the physical well-being but also the psychological well-being of these patients on the short-term and long-term survival. Patients and their families will be assessed on their health-related quality of life and psychological well-being upon hospital discharge using the following scales: Mayo-Portland Adaptability Inventory (MPAI-4), World Health Organization Quality of Life Scale (WHOQOL-BREF), Impact of Event Scale - Revised (IES-R), and Family Resilience Framework. They will also be followed for one year after discharge at 1, 3, 6, and 12 months.
Data will be analyzed using the SPSS and SAS package. Odds ratios and hazards ratios will be determined for the factors that affect survival after cardiac arrest. The findings will help clinicians provide timely support to the patients and their families to promote physical and psychological well-being, and integrate them back to society as soon as possible.
- Conditions
- Post-Cardiac Arrest Syndrome
- Keywords
- Post-cardiac arrest, Holistic care, Family resilience
- Medical subject headings
- Post-Cardiac Arrest Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-cardiac arrest survival
Post-cardiac arrest survival after cardiopulmonary resuscitation
Measured: Up to 1 year after discharge
Neurological outcome - GCS
Using the Glasgow Coma Scale (GCS) of the patients, with scores ranging from 3 to 15, and higher scores indicating a better outcome.
Measured: Up to 1 year after discharge
Neurological outcome - CPC
Cerebral performance categories (CPC) of the patients, with categories 1 and 2 as favorable outcomes, and categories 3 to 5 as unfavorable outcomes
Measured: Up to 1 year after discharge
Functional outcome
Self-reported assessment using the Mayo-Portland Adaptability Index (MPAI-4) for the patients. This is a 29-item scale with overall scores ranging from 0 to 111, and lower scores indicating a better outcome and greater community reintegration post-injury.
Measured: Up to 1 year after discharge
Life quality
Self-reported assessment using the abbreviated World Health Organization Quality of Life questionnaire (WHOQOL-BREF) for the patients. This is a 26-item scale with overall transformed scores ranging from 0 to 100, and higher scores indicating a better quality of life.
Measured: Up to 1 year after discharge
Emotional stress
Self-reported assessment using the Impact of Events Scale - Revised (IES-R) for the patients. This is a 22-item scale with scores ranging from 0 to 88, and higher scores indicating more subjective distress.
Measured: Up to 1 year after discharge
Family resilience
Self-reported assessment using the Family Resilience Framework scale for the patients and their families. This is a 31-item scale with scores ranging from 0 to 155, and higher scores indicating a higher level of resilience.
Measured: Up to 1 year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start12 Apr 2021
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Cardiac Arrest SyndromeStudies 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min-Shan Tsai, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859270
- Sponsor's protocol ID
- 202012242RINB
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2021
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Holistic Health Care of Post-Cardiac Arrest Survivors: From Patient's Health to Family Resilience
- ClinicalTrials.gov ID
- NCT04859270
- Acronym / sponsor ID
- 202012242RINB
- Conditions
- Post-Cardiac Arrest Syndrome
- Keywords
- Post-cardiac arrest, Holistic care, Family resilience
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 26 Apr 2021 (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.
Post-cardiac arrest mortality remains high and proper care after cardiopulmonary resuscitation is an important clinical challenge. This prospective observational cohort aims to (1) identify the factors that affect short-term and long-term survival in post-cardiac arrest survivors and (2) investigate the patients and their families' health-related quality of life and psychological well-being.
Detailed description
For this cohort study, adult survivors (≧20 years) of sudden cardiac arrest for more than 5 minutes after cardiopulmonary resuscitation will be enrolled. Basic demographic information, clinical events throughout hospitalization, and laboratory examination results will be recorded. Patients will be assessed for their neurological outcome using Glasgow coma score (GCS) and cerebral performance categories (CPC) upon hospital discharge, 1, 3, 6, and 12 months after discharge.
Post-cardiac arrest care is clinically challenging and this study aims to evaluate not just the physical well-being but also the psychological well-being of these patients on the short-term and long-term survival. Patients and their families will be assessed on their health-related quality of life and psychological well-being upon hospital discharge using the following scales: Mayo-Portland Adaptability Inventory (MPAI-4), World Health Organization Quality of Life Scale (WHOQOL-BREF), Impact of Event Scale - Revised (IES-R), and Family Resilience Framework. They will also be followed for one year after discharge at 1, 3, 6, and 12 months.
Data will be analyzed using the SPSS and SAS package. Odds ratios and hazards ratios will be determined for the factors that affect survival after cardiac arrest. The findings will help clinicians provide timely support to the patients and their families to promote physical and psychological well-being, and integrate them back to society as soon as possible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The primary participants of the study are patients with out-of-hospital cardiac arrest and achieved return of spontaneous circulation after cardiopulmonary resuscitation. The number of primary participants is 200, and the interviewees are patients and their family members (400), a total of 600 participants.
Key inclusion criteria (1 listed)
- 1. Patients with non-traumatic cardiac arrest, who have successfully sustained return of spontaneous circulation for more than five minutes after resuscitation efforts.
Key exclusion criteria (5 listed)
- Under 20 years of age
- Pregnant
- Terminally ill cancer patients or cancer patients who are unwilling to receive treatment
- When the ICU is over capacity and unable to provide intensive care.
- The patient or family members refused to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-cardiac arrest survival
Time frame: Up to 1 year after discharge
Post-cardiac arrest survival after cardiopulmonary resuscitation
Neurological outcome - GCS
Time frame: Up to 1 year after discharge
Using the Glasgow Coma Scale (GCS) of the patients, with scores ranging from 3 to 15, and higher scores indicating a better outcome.
Neurological outcome - CPC
Time frame: Up to 1 year after discharge
Cerebral performance categories (CPC) of the patients, with categories 1 and 2 as favorable outcomes, and categories 3 to 5 as unfavorable outcomes
Functional outcome
Time frame: Up to 1 year after discharge
Self-reported assessment using the Mayo-Portland Adaptability Index (MPAI-4) for the patients. This is a 29-item scale with overall scores ranging from 0 to 111, and lower scores indicating a better outcome and greater community reintegration post-injury.
Life quality
Time frame: Up to 1 year after discharge
Self-reported assessment using the abbreviated World Health Organization Quality of Life questionnaire (WHOQOL-BREF) for the patients. This is a 26-item scale with overall transformed scores ranging from 0 to 100, and higher scores indicating a better quality of life.
Emotional stress
Time frame: Up to 1 year after discharge
Self-reported assessment using the Impact of Events Scale - Revised (IES-R) for the patients. This is a 22-item scale with scores ranging from 0 to 88, and higher scores indicating more subjective distress.
Family resilience
Time frame: Up to 1 year after discharge
Self-reported assessment using the Family Resilience Framework scale for the patients and their families. This is a 31-item scale with scores ranging from 0 to 155, and higher scores indicating a higher level of resilience.
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 18 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Post-Cardiac Arrest Syndrome
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingObservational study
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome
Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT)
Recruiting
Cerebral Oximetry in Management of Post Cardiac Arrest
Post-Cardiac Arrest Syndrome, Post Cardiac Arrest Brain Injury
Active, not recruitingObservational study
Multiomics Profiling of CSF in Cardiac Arrest Survivors
Cardiac Arrest (CA), Hypoxic-Ischemic Brain Injury
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.
Min-Shan Tsai, MD, PhD 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 Post-Cardiac Arrest Syndrome, 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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. 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?
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?
Contact Min-Shan Tsai, MD, PhD (886-2-23562831, mshanmshan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-cardiac arrest survival (time frame: Up to 1 year after discharge). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2026.