NCT02633358

Brief Summary

Acute myocardial infarction complicated with cardiogenic shock trigger IL-6, the strong inflammatory response, result in multiple organ failure, even death. While therapeutic hypothermia,to expect the possibility of anti-inflammatory effect via IL-6 bi-phasic effect and IL-10 , to improve the multiple organ failure, to increase survival rate and well cerebral performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 23, 2019

Completed
Last Updated

August 7, 2019

Status Verified

July 1, 2019

Enrollment Period

2.8 years

First QC Date

December 8, 2015

Results QC Date

August 19, 2018

Last Update Submit

July 28, 2019

Conditions

Cardiac Arrest

Keywords

Acute myocardial infarction, cardiogenic shock

Outcome Measures

Primary Outcomes (1)

  • Survival Rate - Number of Participants Alive

    Survival rate according to the number of participants alive in the 90 days after enrollment.

    90 days after enrollment

Secondary Outcomes (1)

  • Neurologic Outcome - Number of Participants

    90 days after enrollment

Other Outcomes (3)

  • Interleukin-6 - the Plasma Level of Participants

    between 6 and 24 hours after enrollment.

  • Interleukin-6/Soluble Interleukin-6 Receptor Complex - the Plasma Level of Participants

    between 6 and 24 hours after enrollment

  • Soluble Interleukin-6 Receptor - the Plasma Level of Participants

    between 6 and 24 hours after enrollment

Study Arms (2)

Therapeutic hypothermia group

EXPERIMENTAL

Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling

Device: Therapeutic hypothermia group

Control group

NO INTERVENTION

No therapeutic hypothermia for controlled data.

Interventions

Therapeutic hypothermia groupDEVICE

Therapeutic hypothermia

Therapeutic hypothermia group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-100 years
  • Cardiogenic sock including initial lactate level \>18 mg/dL, necessary of vasopressor to keep mean artery pressure \>65mmHg after adequate fluid supply, and signs of reduced cardiac output including disturbance consciousness, cold limbs, decreased urine output, acute pulmonary congestion and so on.

You may not qualify if:

  • Patient or family refuse
  • Metastatic cancer
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

Related Publications (8)

  • Schmitt KR, Tong G, Berger F. Mechanisms of hypothermia-induced cell protection in the brain. Mol Cell Pediatr. 2014 Dec;1(1):7. doi: 10.1186/s40348-014-0007-x. Epub 2014 Dec 1.

    PMID: 26567101BACKGROUND

  • Bro-Jeppesen J, Kjaergaard J, Stammet P, Wise MP, Hovdenes J, Aneman A, Horn J, Devaux Y, Erlinge D, Gasche Y, Wanscher M, Cronberg T, Friberg H, Wetterslev J, Pellis T, Kuiper M, Nielsen N, Hassager C; TTM-Trial Investigators. Predictive value of interleukin-6 in post-cardiac arrest patients treated with targeted temperature management at 33 degrees C or 36 degrees C. Resuscitation. 2016 Jan;98:1-8. doi: 10.1016/j.resuscitation.2015.10.009. Epub 2015 Oct 23.

    PMID: 26525271BACKGROUND

  • Forkmann M, Kolschmann S, Holzhauser L, Ibrahim K, Guenther M, Christoph M, Fuhrmann JT, Boscheri A, Schmeibetaer A, Strasser RH, Wunderlich C. Target temperature management of 33 degrees C exerts beneficial haemodynamic effects after out-of-hospital cardiac arrest. Acta Cardiol. 2015 Aug;70(4):451-9. doi: 10.1080/ac.70.4.3096893.

    PMID: 26455248BACKGROUND

  • Nobile L, Lamanna I, Fontana V, Donadello K, Dell'anna AM, Creteur J, Vincent JL, Pappalardo F, Taccone FS. Greater temperature variability is not associated with a worse neurological outcome after cardiac arrest. Resuscitation. 2015 Nov;96:268-74. doi: 10.1016/j.resuscitation.2015.09.004. Epub 2015 Sep 16.

    PMID: 26386374BACKGROUND

  • Bro-Jeppesen J, Kjaergaard J, Wanscher M, Nielsen N, Friberg H, Bjerre M, Hassager C. Systemic Inflammatory Response and Potential Prognostic Implications After Out-of-Hospital Cardiac Arrest: A Substudy of the Target Temperature Management Trial. Crit Care Med. 2015 Jun;43(6):1223-32. doi: 10.1097/CCM.0000000000000937.

    PMID: 25756419BACKGROUND

  • Dankiewicz J, Nielsen N, Annborn M, Cronberg T, Erlinge D, Gasche Y, Hassager C, Kjaergaard J, Pellis T, Friberg H. Survival in patients without acute ST elevation after cardiac arrest and association with early coronary angiography: a post hoc analysis from the TTM trial. Intensive Care Med. 2015 May;41(5):856-64. doi: 10.1007/s00134-015-3735-z. Epub 2015 Mar 24.

    PMID: 25800582BACKGROUND

  • Chen D, Lin Y, Ko P, Lin J, Huang C, Wang G, Chang KC. Effect of targeted temperature management on systemic inflammatory responses after out-of-hospital cardiac arrest: A prospective cohort study. Medicine (Baltimore). 2024 Sep 20;103(38):e39780. doi: 10.1097/MD.0000000000039780.

    PMID: 39312301DERIVED

  • Chen DL, Chung CM, Wang GJ, Chang KC. Lactate-to-albumin ratio and cholesterol levels predict neurological outcome in cardiac arrest survivors. Am J Emerg Med. 2024 Sep;83:9-15. doi: 10.1016/j.ajem.2024.06.029. Epub 2024 Jun 25.

    PMID: 38943710DERIVED

MeSH Terms

Conditions

Heart ArrestShock, Cardiogenic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial InfarctionMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Limitations and Caveats

Pregnancy, terminal and metastatic cancer, uncontrolled bleeding and family refuse inform consent had been excluded.

Results Point of Contact

Title
Dr. Da-Long Chen, director of cardiac intensive care unit
Organization
China Medical University Hospital, Taichung, Taiwan
my686chen@gmail.com
0952122027

Study Officials

  • Da-Long Chen, Master

    Chnia Medical University Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2015

First Posted

December 17, 2015

Study Start

November 1, 2015

Primary Completion

August 18, 2018

Study Completion

August 18, 2018

Last Updated

August 7, 2019

Results First Posted

July 23, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)