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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.
Despite emergency coronary revascularization coupled with medical stabilization, intra-aortic balloon pump have significantly improved survival in patients with cardiogenic shock complicating acute myocardial infarction, mortality still remains excessively high, being actually about 30-50%. Future research should focus on new therapeutic strategies, aimed to further decrease mortality rate of these patients or improve possible hospitalization and prognosis.
Heart pumping failure result in cardiogenic shock. Increased LA filling pressure result in acute pulmonary edema, hypoxemic respiratory failure, even congestive kidney and congestive liver. Decreased stroke volume result in hypoperfusion obviously direct induce acute renal failure, disturbance consciousness and lactate accumulation, even, shock liver. Multiple organ failure is the major mortality in the patients suffered from cardiogenic shock after acute myocardial infarction.
Cardiogenic shock remains the leading cause of death in patients hospitalized for myocardial infarction . Systemic inflammation , especially endovascular Interleukin-6, triggered by Tumor necrosis factor-alfa and Interleukin-1 beta result in inappropriate vasodilatation is observed in many patients with cardiogenic shock and may contribute to an excess mortality rate. In recent study, interleukin-6 represented a reliable independent early prognostic marker of 30-day mortality.
Therapeutic hypothermia (34℃) increase stroke volume, reduce muscle oxygen consumption and enhance anti-inflammatory action . The mechanism of anti-inflammatory effect for therapeutic hypothermia in cardiogenic shock is still unclear, need to further study in clinical trial. Furthermore, this study will provide new strategy to increase survival rate in cardiogenic shock.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic hypothermia group | Experimental | Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling |
|
| Control group | No Intervention | No therapeutic hypothermia for controlled data. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic hypothermia group | Device | Therapeutic hypothermia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Neurologic Outcome - Number of Participants | Neurological outcome according to Cerebral performance Category scales: scales 1-2 in favor of favorable neurological outcome; scales 3-5 in favor of poor neurological outcome including severe cerebral disability, coma or vegetative state, brain death. | 90 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin-6 - the Plasma Level of Participants | IL-6 level change | between 6 and 24 hours after enrollment. |
| Interleukin-6/Soluble Interleukin-6 Receptor Complex - the Plasma Level of Participants | Interleukin-6/soluble Interleukin-6 receptor complex plasma level hint the pro-inflammatory pathway via Interleukin-6 trans-signaling |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Da-Long Chen, Master | Chnia Medical University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26567101 | Background | 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. | |
| 26525271 | Background | 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. |
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Recruitment period: 2015 Jan. to 2018 Apr. Types of location: Cardiac intensive care units, China Medical University Hospital, Taichung, Taiwan
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| ID | Title | Description |
|---|---|---|
| FG000 | Therapeutic Hypothermia | Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling Therapeutic hypothermia: Therapeutic hypothermia |
| FG001 | Non-hypothermia | Control group for non-hypothermia. Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Total 141 patients involved in this study. 87 patients divided in the therapeutic hypothermia group and 54 patients divided in the control group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Therapeutic Hypothermia | Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling Therapeutic hypothermia: Therapeutic hypothermia |
| BG001 | Non-Hypothermia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survival Rate - Number of Participants Alive | Survival rate according to the number of participants alive in the 90 days after enrollment. | Randomized divided to two groups including therapeutic hypothermia group and non-hypothermia group | Posted | Count of Participants | Participants | 90 days after enrollment |
|
90-day follow up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Therapeutic Hypothermia | Adverse events including ventricular arrhythmia, active bleeding, death due to lower core temperature less than 32 degree Celsius. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe cerebral disability | Nervous system disorders | Systematic Assessment | Severe cerebral disability |
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Pregnancy, terminal and metastatic cancer, uncontrolled bleeding and family refuse inform consent had been excluded.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Da-Long Chen, director of cardiac intensive care unit | China Medical University Hospital, Taichung, Taiwan | 0952122027 | my686chen@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2018 | May 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
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| between 6 and 24 hours after enrollment |
| Soluble Interleukin-6 Receptor - the Plasma Level of Participants | Check the soluble Interleukin-6 plasma level at 6 hours and 24 hours after enrollment | between 6 and 24 hours after enrollment |
| 26455248 | Background | 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. |
| 26386374 | Background | 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. |
| 25756419 | Background | 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. |
| 25800582 | Background | 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. |
| 39312301 | Derived | 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. |
| 38943710 | Derived | 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. |
Control group for non-hypothermia. Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Neurologic Outcome - Number of Participants | Neurological outcome according to Cerebral performance Category scales: scales 1-2 in favor of favorable neurological outcome; scales 3-5 in favor of poor neurological outcome including severe cerebral disability, coma or vegetative state, brain death. | Randomized divided to two groups including therapeutic hypothermia group and non-hypothermia group | Posted | Count of Participants | Participants | 90 days after enrollment |
|
|
|
|
| Other Pre-specified | Interleukin-6 - the Plasma Level of Participants | IL-6 level change | Randomized divided to two groups including therapeutic hypothermia and non-hypothermia group | Posted | Mean | Standard Error | pg/mL | between 6 and 24 hours after enrollment. |
|
|
|
|
| Other Pre-specified | Interleukin-6/Soluble Interleukin-6 Receptor Complex - the Plasma Level of Participants | Interleukin-6/soluble Interleukin-6 receptor complex plasma level hint the pro-inflammatory pathway via Interleukin-6 trans-signaling | Posted | Mean | Standard Error | pg/mL | between 6 and 24 hours after enrollment |
|
|
|
|
| Other Pre-specified | Soluble Interleukin-6 Receptor - the Plasma Level of Participants | Check the soluble Interleukin-6 plasma level at 6 hours and 24 hours after enrollment | Posted | Mean | Standard Error | ng/mL | between 6 and 24 hours after enrollment |
|
|
|
|
| 32 |
| 87 |
| 57 |
| 87 |
| 0 |
| 87 |
| EG001 | Non-Hypothermia | Adverse events including ventricular arrhythmia, active bleeding, death due to lower core temperature less than 32 degree Celsius. | 34 | 54 | 44 | 54 | 0 | 54 |
|
| Coma or vegetative state | Nervous system disorders | Systematic Assessment | Coma or vegetative state |
|
| Brain death | Nervous system disorders | Systematic Assessment | Brain death |
|
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| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |