Cardiac ArrestNCT06660238
PET-CT to Assess Brain Damage in Cardiac Arrest Patients
An observational study of Cardiac Arrest and Brain Injuries, run by Capital Medical University at 1 site in China.
Trial summary
This was a single-center, observational study. Patients with successful cardiopulmonary resuscitation (CPR) will be transferred to the emergency intensive care unit for further standardized management. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrest, Brain Injuries
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 31 Dec 2027
- How long will I take part?
- 6 Months
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after successful cardiopulmonary resuscitation (CPR) were transferred to the emergency intensive care unit for further standardized management.
Who may be able to join
- age ≥18 years.
- sustained hemodynamic stability for ≥24h.
- the patients were unconscious and not able to obey verbal commands. • Advanced life support and target temperature management within 6 hours of return of spontaneous circulation (ROSC).
Who cannot join
- Patients with hemodynamic instability.
- Patients who could not complete cranial PET-CT examination for special reasons. • Patients during pregnancy.
- Patients who combined traumatic brain injury, stroke, cerebral hemorrhage and other diseases.
- Patients whose family members did not agree to be enrolled.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing chaoyang hospital
Beijing, Beijing Municipality, 100020
Weijie Cheng, M.D, +86 18980360089, chengweijie@mail.ccmu.edu.cn
About this study
Official title: Assessment of Cerebral Metabolism, Cerebral Blood Flow and Cerebral Oxygen Damage in Patients With Cardiac Arrest Using PET-CT
This was a single-center, observational study. Patients with successful cardiopulmonary resuscitation (CPR) will be transferred to the emergency intensive care unit for further standardized management. After successful return of spontaneous circulation (ROSC) for 72 hours and hemodynamic stability for 24 hours, the patients underwent positron emission computed tomography (PET-CT) examination after resuscitation. The supervising physician accompanied the patient and used monitors to monitor vital signs during the examination. Patients who were on ventilators were mechanically ventilated with a magnetic ventilator (HAMILTON-MRI, United States). In addition to conventional cerebral oxygen metabolism, cerebral blood flow, oxygen extraction fraction, cerebral blood volume and other indicators were added in this experiment. These indicators can evaluate the patient's cerebral metabolism, cerebral blood flow and cerebral blood oxygen damage degree. The neurological outcome was followed up 6 months after onset according to the cerebral performance category（CPC）.
- Conditions
- Cardiac Arrest, Brain Injuries
- Being tested
- No interventions
- Keywords
- Cardiac arrest, Positron Emission Tomography-Computed Tomography, cerebral metabolism, cerebral blood flow, cerebral oxygenation
- Medical subject headings
- Heart Arrest, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurologic prognosis
Patients will be followed up for neurologic prognosis according to the Cerebral Performance Category Scale（CPC）at 6 months after disease onset.The CPC score was divided into five grades. Grade 1 represented intact brain function, the patient was awake and alert, and had the ability to live and work normally. Grade 2 represents moderate cerebral disability, in which the person is awake and able to work part of the time in a specific environment or perform daily activities independently; Grade 3, severe cerebral disability: the person is awake but dependent on others for daily assistance and retains limited cognition; Grade 4 represents coma and vegetative state, the patient is unconscious, unconscious to the environment, and has no cognitive ability; Level 5 represents death, with the patient confirmed as brain death or death by traditional criteria. According to the CPC score, grade 1-2 was defined as good neurological outcome, and grade 3-5 was defined as poor neurological outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tang Ziren, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660238
- Sponsor's protocol ID
- 2024-9-26-836
- Status last verified
- Apr 2025
- First submitted
- 22 Oct 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cerebral Metabolism, Cerebral Blood Flow and Cerebral Oxygen Damage in Patients With Cardiac Arrest Using PET-CT
- ClinicalTrials.gov ID
- NCT06660238
- Acronym / sponsor ID
- 2024-9-26-836
- Conditions
- Cardiac Arrest, Brain Injuries
- Keywords
- Cardiac arrest, Positron Emission Tomography-Computed Tomography, cerebral metabolism, cerebral blood flow, cerebral oxygenation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Oct 2024 (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.
This was a single-center, observational study. Patients with successful cardiopulmonary resuscitation (CPR) will be transferred to the emergency intensive care unit for further standardized management. After successful return of spontaneous circulation (ROSC) for 72 hours and hemodynamic stability for 24 hours, the patients underwent positron emission computed tomography (PET-CT) examination after resuscitation. The supervising physician accompanied the patient and used monitors to monitor vital signs during the examination. Patients who were on ventilators were mechanically ventilated with a magnetic ventilator (HAMILTON-MRI, United States). In addition to conventional cerebral oxygen metabolism, cerebral blood flow, oxygen extraction fraction, cerebral blood volume and other indicators were added in this experiment. These indicators can evaluate the patient's cerebral metabolism, cerebral blood flow and cerebral blood oxygen damage degree. The neurological outcome was followed up 6 months after onset according to the cerebral performance category（CPC）.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after successful cardiopulmonary resuscitation (CPR) were transferred to the emergency intensive care unit for further standardized management.
Key inclusion criteria (3 listed)
- age ≥18 years.
- sustained hemodynamic stability for ≥24h.
- the patients were unconscious and not able to obey verbal commands. • Advanced life support and target temperature management within 6 hours of return of spontaneous circulation (ROSC).
Key exclusion criteria (4 listed)
- Patients with hemodynamic instability.
- Patients who could not complete cranial PET-CT examination for special reasons. • Patients during pregnancy.
- Patients who combined traumatic brain injury, stroke, cerebral hemorrhage and other diseases.
- Patients whose family members did not agree to be enrolled.
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 |
|---|---|---|
| No interventionsNo interventions | Other | – |
Primary outcome
Neurologic prognosis
Time frame: 6 months
Patients will be followed up for neurologic prognosis according to the Cerebral Performance Category Scale（CPC）at 6 months after disease onset.The CPC score was divided into five grades. Grade 1 represented intact brain function, the patient was awake and alert, and had the ability to live and work normally. Grade 2 represents moderate cerebral disability, in which the person is awake and able to work part of the time in a specific environment or perform daily activities independently; Grade 3, severe cerebral disability: the person is awake but dependent on others for daily assistance and retains limited cognition; Grade 4 represents coma and vegetative state, the patient is unconscious, unconscious to the environment, and has no cognitive ability; Level 5 represents death, with the patient confirmed as brain death or death by traditional criteria. According to the CPC score, grade 1-2 was defined as good neurological outcome, and grade 3-5 was defined as poor neurological outcome.
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 11 Apr 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
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 Brain Injuries, run by Capital Medical University at 1 site in China.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Apr 2025. 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 China. 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 Ziren Tang (+86 010-85231530, tangziren1970@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurologic prognosis (time frame: 6 months). 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 11 Apr 2025.