NCT04859270

Brief 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 their families' health-related quality of life and psychological well-being.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

July 18, 2025

Status Verified

February 1, 2025

Enrollment Period

4.8 years

First QC Date

April 14, 2021

Last Update Submit

July 16, 2025

Conditions

Post-Cardiac Arrest Syndrome

Keywords

Post-cardiac arrestHolistic careFamily resilience

Outcome Measures

Primary Outcomes (7)

  • Post-cardiac arrest survival

    Post-cardiac arrest survival after cardiopulmonary resuscitation

    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.

    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

    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.

    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.

    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.

    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.

    Up to 1 year after discharge

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \. Patients with non-traumatic cardiac arrest, who have successfully sustained return of spontaneous circulation for more than five minutes after resuscitation efforts.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Post-Cardiac Arrest Syndrome

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeart DiseasesCardiovascular DiseasesReperfusion InjuryVascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Min-Shan Tsai, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min-Shan Tsai, MD, PhD

CONTACT

886-2-23562831mshanmshan@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 26, 2021

Study Start

April 12, 2021

Primary Completion

January 31, 2026

Study Completion

March 31, 2026

Last Updated

July 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)