Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack? (CHIPAHA)
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|ClinicalTrials.gov Identifier: NCT00763828|
Recruitment Status : Not yet recruiting
First Posted : October 1, 2008
Last Update Posted : September 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|ST-Elevation Myocardial Infarction||Device: Life Recovery Systems ThermoSuit||Not Applicable|
This clinical study will investigate the safety and feasibility of cooling heart attack (STEMI) patients with the LRS (Life Recovery Systems)ThermoSuit System, a cooling device which uses the principle of cold water immersion to rapidly reduce patient temperature. The study will enroll a total of up to 20 patients, and will be a cooperative effort between LRS and LSU Health Sciences Center - Shreveport.
The study is being conducted under an IDE (Investigational Device Exemption) that was granted to LRS by FDA (G070141). The primary goal of this trial is to demonstrate the feasibility of cooling AMI patients pre-reperfusion with the ThermoSuit cooling device. The safety of this treatment will be determined by review of a composite of serious adverse events.
Consciously sedated patients will be cooled after entry into the emergency room and prior to percutaneous coronary intervention in the catheterization laboratory. It is hypothesized that the ThermoSuit System will enable cooling of the patient to 34ºC after a treatment of 30 minutes or less. Previous research has suggested that cooling of ST-elevation myocardial infarction patients before coronary reperfusion could result in a significant reduction in myocardial infarct size.
If successful, this study will lead to a pivotal clinical study to investigate the potential for the ThermoSuit cooling treatment to reduce myocardial infarct size. The ultimate goal of these studies is to determine the safety and effectiveness of the use of the ThermoSuit device for the treatment of AMI patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?|
|Estimated Study Start Date :||February 28, 2021|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||August 31, 2022|
Experimental: ThermoSuit-Induced Patient Cooling
The Life Recovery Systems ThermoSuit System will be used to cool STEMI patients under conditions of conscious sedation.
Device: Life Recovery Systems ThermoSuit
Hypothermia induction (cooling to 32 to 34 degrees C core temperature) using the Life Recovery Systems ThermoSuit System (a device which cools patients using direct skin contact with cold water) followed by PCI (percutaneous coronary intervention) and maintenance of hypothermia for 3 hours following PCI.
Other Name: Life Recovery Systems ThermoSuit(R) System
- Feasibility of use of cooling device as determined by ability and time to achieve target temperature and ease of maintaining temperature in therapeutic range (32 to 34°C) for three hours following removal of patient from ThermoSuit. [ Time Frame: Four hours ]
- Primary safety endpoint: composite of serious adverse events including: death, re-infarction, ischemia-driven TVR, pneumonia, sepsis, arrhythmia, bleeding, stroke, and renal failure. [ Time Frame: 30 days post-hospital discharge ]
- Major adverse cardiac events at 30 days as defined by death or non-fatal re-infarction. c. Ischemia-driven target vessel revascularization. [ Time Frame: 30 days post-hospital discharge ]
- Myocardial infarct size at 30 days as measured by 99mTc-sestamibi SPECT imaging. [ Time Frame: 30 days post-hospital discharge ]
- Safety, including all-cause mortality, cardiac, vascular, and hematological complications. [ Time Frame: 30 days post-hospital discharge ]
- Adverse events associated with conscious sedation. [ Time Frame: 30 days post-hospital discharge ]
- Arterial blood pressure and heart rate every 5 minutes from the baseline just before the start of cooling until 30 minutes after cooling has started. [ Time Frame: One hour ]
- Door to balloon time. [ Time Frame: 90 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763828
|Contact: Robert B Schock, Ph.D.||firstname.lastname@example.org|
|Contact: Rick Hettenbach, MAemail@example.com|
|Study Chair:||Robert J Freedman, M.D.||Life Recovery Systems|