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Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate whether induction of mild hypothermia in addition to primary percutaneous coronary intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic shock improves cardiac power index after 24 h.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild hypothermia | Experimental | Induction of mild hypothermia for 24 hr with invasive cooling in addition to primary percutaneous coronary intervention and optimal medical therapy |
|
| Control | No Intervention | Percutaneous coronary intervention and optimal medical therapy according to current guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mild hypothermia | Procedure | Induction of mild hypothermia with invasive cooling for 24 hr in addition to primary percutaneous coronary intervention and optimal medical therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Power Index after 24 hr. | Cardiac Power Index after 24 hours as surrogate endpoint. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 30-days mortality | 30 days | |
| Change of hemodynamics over the first 48 hr. | During first 48 hr | |
| Catecholamine dose and duration of catecholamine support |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holger Thiele, MD | Heart Center Leipzig - University Hospital | Study Chair |
| Georg Fuernau, MD | Heart Center Leipzig - University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center | Leipzig | Saxony | 04289 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36005444 | Derived | Cheng W, Fuernau G, Desch S, Freund A, Feistritzer HJ, Poss J, Buettner P, Thiele H. Circulating Monocyte Chemoattractant Protein-1 in Patients with Cardiogenic Shock Complicating Acute Myocardial Infarction Treated with Mild Hypothermia: A Biomarker Substudy of SHOCK-COOL Trial. J Cardiovasc Dev Dis. 2022 Aug 20;9(8):280. doi: 10.3390/jcdd9080280. | |
| 30026282 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D007036 | Hypothermia, Induced |
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D013812 | Therapeutics |
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| 30 days |
| Length of ICU-stay | 30 days |
| Length of mechanical ventilation | 30 days |
| SAPS-II-Score | Simplified Acute Physiology Score for the first 4 days | 96 hours |
| Severe and moderate bleeding complications (GUSTO-definition) | 30 days |
| Sepsis | 30 days |
| Pneumonia | 30 days |
| Stroke | 30 days |
| Fuernau G, Beck J, Desch S, Eitel I, Jung C, Erbs S, Mangner N, Lurz P, Fengler K, Jobs A, Vonthein R, de Waha-Thiele S, Sandri M, Schuler G, Thiele H. Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction. Circulation. 2019 Jan 22;139(4):448-457. doi: 10.1161/CIRCULATIONAHA.117.032722. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |