Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001570875
Ethics application status
Approved
Date submitted
15/02/2021
Date registered
18/11/2021
Date last updated
18/11/2021
Date data sharing statement initially provided
18/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of cooling therapy on blood cell death in patients who developed cardiac arrest after a heart attack, whose heartbeat was restored and who received body cooling therapy.
Scientific title
The Effect of Targeted Temperature Management Therapy on Pyroptosis in Patients with return of Spontaneous Circulation post Cardiac Arrest Caused by Acute Myocardial Infarction.
Secondary ID [1] 303443 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac arrest 320747 0
myocardial infarction 323015 0
Condition category
Condition code
Emergency medicine 318586 318586 0 0
Resuscitation
Cardiovascular 320579 320579 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Target-Oriented Temperature Therapy, with spontaneous circulation after cardiac arrest caused by Acute Myocardial Infarction, patients over 18 years of age were included.

Patients under 18 years of age and those who died during 48 hours of hypothermia were excluded.
*Patients will be evaluated by the Cardiology department before the hypothermia procedure and cardiac examination of the patient will be performed.

* Hypothermia process will start within the first 6 hours after the arrest by intensive care team. External targeted temperature therapy will be applied to the patients with the help of cold pads at 34°C for 48 hours. Samples will be stored at -80 °C after taking venous blood from the patients three times at the beginning of the cooling treatment (0.hour), at the 24th hour of the treatment and at the end of the treatment (48.hour) and centrifuged appropriately.

*Patients will be re-evaluated by the cardiology department after the hypothermia procedure ends.

* After reaching the number of patients, NLRP3, caspase1, gasdermin and IL-1Beta proteins will be measured by ELISA method and pyroptosis levels will be measured and recorded.
Intervention code [1] 319743 0
Diagnosis / Prognosis
Intervention code [2] 321285 0
Treatment: Other
Comparator / control treatment
In order to compare the measured values, 15 male and 15 female healthy volunteers without cardiac pathology will be considered as the CONTROL group, and NLRP3, caspase1, gasdermin and IL-1Beta proteins in their blood will be measured.
Control group
Active

Outcomes
Primary outcome [1] 326562 0
To investigate the effect of Goal-Oriented Temperature Therapy on pyroptosis (Pyroptosis measured as a composite of NLRP3, caspase-1, and IL-1Beta protein levels on a venous blood sample using ELISA) in patients with spontaneous circulation after cardiac arrests caused by acute myocardial infarction.
Timepoint [1] 326562 0
Venous blood was drawn at the start of the cooling therapy (0 hr), within 24 h of treatment and at the end of treatment (48 h).
Secondary outcome [1] 391902 0
mortality ; by accessing patient medical record
Timepoint [1] 391902 0
48 hours post-intervention commencement

Eligibility
Key inclusion criteria
The criteria for inclusion were a witnessed cardiac arrest, a presumed cardiac origin of the arrest, an age of 18 to 70 years, an estimated interval of 5 to 15 minutes from the patient's collapse to the first attempt at resuscitation by emergency medical personnel, and an interval of no more than 60 minutes from collapse to restoration of spontaneous circulation.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded if they met any of the following criteria: esophageal temperature below 30 ° C at admission, coma before cardiac arrest due to administration of drugs that suppress the central nervous system, pregnancy, then response to verbal commands, return of spontaneous circulation, and before randomization, spontaneous Evidence of hypotension (mean arterial pressure less than 60 mm Hg), evidence of hypoxaemia (arterial oxygen saturation less than 85 percent) after return of circulation and more than 30 minutes prior to randomization, after return of spontaneous circulation and more than 15 minutes prior to randomization a fatal illness that occurred prior to arrest, factors unlikely to participate in follow-up, enrollment in another study, or a known pre-existing coagulopathy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
30
Final
Recruitment outside Australia
Country [1] 23463 0
Turkey
State/province [1] 23463 0
Sanliurfa

Funding & Sponsors
Funding source category [1] 307864 0
University
Name [1] 307864 0
harran university scientific research project coordination unit
Country [1] 307864 0
Turkey
Primary sponsor type
University
Name
harran university medical faculty
Address
Sanliurfa-Mardin Highway 18.Km Sanliurfa / Turkey
Country
Turkey
Secondary sponsor category [1] 308573 0
None
Name [1] 308573 0
none
Address [1] 308573 0
none
Country [1] 308573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307867 0
harran university medical faculty ethics committe
Ethics committee address [1] 307867 0
Ethics committee country [1] 307867 0
Turkey
Date submitted for ethics approval [1] 307867 0
Approval date [1] 307867 0
27/04/2020
Ethics approval number [1] 307867 0
20.21.13

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108750 0
Dr mahmut alp karahan
Address 108750 0
Harran University Faculty of Medicine Sanliurfa-Mardin Highway, 18.Km, 63300 Sanliurfa.
Country 108750 0
Turkey
Phone 108750 0
+905327808997
Fax 108750 0
Email 108750 0
[email protected]
Contact person for public queries
Name 108751 0
mahmut alp karahan
Address 108751 0
Harran University Faculty of Medicine Sanliurfa-Mardin Highway, 18.Km, 63300 Sanliurfa.
Country 108751 0
Turkey
Phone 108751 0
+905327808997
Fax 108751 0
Email 108751 0
[email protected]
Contact person for scientific queries
Name 108752 0
mahmut alp karahan
Address 108752 0
Harran University Faculty of Medicine Sanliurfa-Mardin Highway, 18.Km, 63300 Sanliurfa.
Country 108752 0
Turkey
Phone 108752 0
+905327808997
Fax 108752 0
Email 108752 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Researchers are not allowed to share data from participants


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.