An interventional study of Life Recovery Systems ThermoSuit in ST-Elevation Myocardial Infarction, sponsored by Life Recovery Systems. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-10.
Sponsored by Life Recovery Systems · Not applicable, Interventional, and Treatment
Among 82 studies in ST Elevation Myocardial Infarction with a site in United States — 5 open to participants now, 11 under way, 1 of them phase 3. ST Elevation Myocardial Infarction · United States.
Among the 82 studies in ST Elevation Myocardial Infarction with a site in United States, this one is the 44th largest by planned enrollment of the 55 interventional ones that give a count, is one of 5 that started in 2024, is one of 22 with no phase, reaches primary completion later than 1 of the 10 other live ones, and was the 11th registered.
851 studies on the registry are indexed under ST Elevation Myocardial Infarction; 198 are open to participants now.
Browse ST Elevation Myocardial Infarction studies →5 of the 82 studies in ST Elevation Myocardial Infarction with a site in United States are open now. Recruiting first, the newest first:
The Cleveland Clinic · Sites in United States
Ages 18+
TherOx · Sites in United States
Ages 18–80
Nabeel Hamzeh · Sites in United States
Ages 18+ · Healthy volunteers
Peerbridge Health, Inc · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 122 ST Elevation Myocardial Infarction studies recruiting now, 76 (62%) set no upper age limit and 20 (16%) stop at 75 or younger; 10 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
82 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 14 · Phase 3 9 · Phase 4 8
First in 2003; this study’s year is marked. 5 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 193 across 528 interventional studies indexed under ST Elevation Myocardial Infarction.
Median enrollment 100 across the 55 interventional studies, 324 across the 27 observational. Of the 59 that completed or were terminated, 26 (44%) have results posted.
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33 of 82 have an industry lead sponsor. The 10 most frequent:
Life Recovery Systems is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Life Recovery Systems has 1 study filed under ST Elevation Myocardial Infarction — fewer than ten, so there is no comparison to draw.
3 of the studies in ST Elevation Myocardial Infarction with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05800951Henry Ford Health SystemCan Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock | 2026-12-31 |
| NCT06438315TherOxSuperSaturated Oxygen Comprehensive Observational Registry | 2027-03 |
| NCT05284747AmgenEVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction | 2027-05-29 |
Add all 3 to your calendar (.ics) → With an account.
Among the 82 studies in ST Elevation Myocardial Infarction with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The hypothesis of this study is that consciously sedated patients suffering from ST-elevation myocardial infarction can be rapidly and safely cooled to a state of therapeutic hypothermia (32 to 34 degrees C) using the LRS ThermoSuit System prior to percutaneous coronary intervention.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: 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
Start is estimated for Jan 2024; primary completion for Feb 2025, 13 months later.
Of 134 non-industry interventional studies with no phase under ST Elevation Myocardial Infarction, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's planned 13 months is below that.
Counting every sponsor, half of 143 studies reached it within 38 months; a quarter within 19 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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ST Elevation Myocardial Infarction →
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