ST-Elevation Myocardial InfarctionCHIPAHANCT00763828
Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?
A study testing Life Recovery Systems ThermoSuit in people with ST-Elevation Myocardial Infarction, run by Life Recovery Systems at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-Elevation Myocardial Infarction
- What is being tested?
- Life Recovery Systems ThermoSuit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Duration of MI symptoms ≥ 30 minutes to ≤ 6 hours.
- ST-segment elevation of ≥ 1mm or more in two or more contiguous leads.
- Eligible for PCI.
- Willingness of patient or legal guardian to provide written, informed consent.
- Patient dimension criteria:
- Height: 147-190 cm (58 - 75 in)
- Width: ≤73 cm (29 in) (elbow to elbow)
Who cannot join
- Cardiac arrest or previous MI within one month.
- Administration of thrombolytics.
- Cardiogenic shock (systolic blood pressure (SBP) < 80 mmHg for > 30 minutes or SBP < 100 mmHg on vasopressors or IABP) in the absence of bradycardia or other correctable causes.
- Known hypersensitivity to hypothermia including Raynaud's disease or cryoglobulinemia.
- Severe allergy or contraindication to aspirin, Plavix, heparin, or contrast media which cannot be adequately pre-medicated.
- History of bleeding diathesis or coagulopathy or refusal of blood transfusions.
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- Pregnancy.
- Known hypersensitivity midazolam, meperidine, buspirone, or magnesium sulfate.
- Current enrollment in another clinical trial (other than registry).
- Temperature < 35°C on admission to Emergency Department.
- Recent (< 1 week) surgical incisions.
Trial locations and contacts
1 site in 1 country.
United States1 site
UTHSCSA
San Antonio, Texas, 78229-3900
Steven R Bailey, MD, 210-567-3885, BailyS@uthscsa.edu
Joan Drake, RN, BSN, MPH, 210-567-8692, DrakeP@uthscsa.edu
About this study
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.
Read the detailed description
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.
- Conditions
- ST-Elevation Myocardial Infarction
- Being tested
- Life Recovery Systems ThermoSuit
- Keywords
- Myocardial Infarction, Hypothermia, Induced
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Recovery Systems ThermoSuitDevice
Also called Life Recovery Systems ThermoSuit(R) System
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.
| Study group | Role | What they receive |
|---|---|---|
| ThermoSuit-Induced Patient Cooling | Experimental | The Life Recovery Systems ThermoSuit System will be used to cool STEMI patients under conditions of conscious sedation. Receives: Device: Life Recovery Systems ThermoSuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days post-hospital discharge
Secondary outcomes (6)
Major adverse cardiac events at 30 days as defined by death or non-fatal re-infarction. c. Ischemia-driven target vessel revascularization.
Measured: 30 days post-hospital discharge
Myocardial infarct size at 30 days as measured by 99mTc-sestamibi SPECT imaging.
Measured: 30 days post-hospital discharge
Safety, including all-cause mortality, cardiac, vascular, and hematological complications.
Measured: 30 days post-hospital discharge
Adverse events associated with conscious sedation.
Measured: 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.
Measured: One hour
Door to balloon time.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study start28 Jan 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Life Recovery Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert J Freedman, M.D., Study chair, Life Recovery Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763828
- Sponsor's protocol ID
- LRS-01-07-01
- Acronym
- CHIPAHA
- Status last verified
- Mar 2023
- First submitted
- 30 Sep 2008
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?
- ClinicalTrials.gov ID
- NCT00763828
- Acronym / sponsor ID
- CHIPAHA / LRS-01-07-01
- Conditions
- ST-Elevation Myocardial Infarction
- Keywords
- Myocardial Infarction, Hypothermia, Induced
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Life Recovery SystemsUniversity, hospital or other
- Study start
- 28 Jan 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ThermoSuit-Induced Patient Cooling | Experimental | Device: Life Recovery Systems ThermoSuitThe Life Recovery Systems ThermoSuit System will be used to cool STEMI patients under conditions of conscious sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years.
- Duration of MI symptoms ≥ 30 minutes to ≤ 6 hours.
- ST-segment elevation of ≥ 1mm or more in two or more contiguous leads.
- Eligible for PCI.
- Willingness of patient or legal guardian to provide written, informed consent.
Key exclusion criteria (11 listed)
- Cardiac arrest or previous MI within one month.
- Administration of thrombolytics.
- Cardiogenic shock (systolic blood pressure (SBP) < 80 mmHg for > 30 minutes or SBP < 100 mmHg on vasopressors or IABP) in the absence of bradycardia or other correctable causes.
- Known hypersensitivity to hypothermia including Raynaud's disease or cryoglobulinemia.
- Severe allergy or contraindication to aspirin, Plavix, heparin, or contrast media which cannot be adequately pre-medicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life Recovery Systems ThermoSuitAlso: Life Recovery Systems ThermoSuit(R) SystemHypothermia 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. | Device | ThermoSuit-Induced Patient Cooling |
Primary outcome
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
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Freedman, M.D. study chair
Life Recovery Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life Recovery Systems ThermoSuit in people with ST-Elevation Myocardial Infarction, run by Life Recovery Systems at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert B Schock, Ph.D. (973-283-2800, bschock@life-recovery.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.