Ischemic StrokePhase 2HELMETNCT02985060
Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke
A Phase 2 study testing Arctic Sun, Standard treatment and Saline in people with Ischemic Stroke and Thrombolytic Therapy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To study safety and feasibility of mild therapeutic hypothermia after successful recanalization by mechanical endovascular treatment in patients with acute ischemic stroke and proximal arterial occlusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Thrombolytic Therapy
- What is being tested?
- Arctic Sun, Standard treatment and Saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2016to Nov 2017
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who submitted a written informed consent prior to the participation in the current clinical trial (If the subjects have conditions that they cannot decide on study participation according to their own will, they would participate in the study after their legal representatives submitted a written informed consent form. During the period of study participation, if patients' medical conditions are improved, the written informed consent should be submitted again.)
- Patients with ischemic stroke attributed to carotid artery or middle cerebral artery occlusion achieved successful recanalization (TICI 2b or 3) immediately after endovascular treatment within 8 hours of symptom onset: Onset time was defined as the time when patients were lastly seen normal.
- Patients of both sexes aged between 18 and 80 years old
- NIHSS scores of 6-25 points at screening
- mRS 1 prior to the onset of disease, with proximal cerebral artery occlusion (e.g., those with middle cerebral or internal carotid artery)
Who cannot join
- No evaluation for cranial artery before endovascular treatment
- Patient with emergent stenting insertion in intracranial or extracranial artery
- Transient ischemic attack or lacunar infarction
- Platelet counts < 75,000/mm3
- coagulopathy (INR spontaneously >1.5)
- Hemodynamic instability
Show all 15Show fewer
- acute myocardial infarction, acute unstable angina or severe cardiac failure (NYHA classification ≥III)
- Sepsis
- Pregnant or breastfeeding women
- Premorbid modified Rankin Scale Scores of > 2 points
- Hypersensitivity or allergy to following: buspirone, dexmedetomidine, meperidine
- Intracranial hemorrhage or hemorrhagic transformation in initial CT scan
- Brain tumor or CNS infection
- Patients who participated in other clinical trials within 3 months
- Life expectancy within 1 year
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang
Seongnam, Gyeoinggido, 13620
MOON-KU HAN, professor, 82-31-787-7464, mkhan@snu.ac.kr
JEONG-HO HONG, professor, 82-53-250-7317, neurohong79@mail.com
About this study
Official title: Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke; Prospective, Open, Randomized, Multicenter Phase II Study
To study safety and feasibility of mild therapeutic hypothermia after successful recanalization by mechanical endovascular treatment in patients with acute ischemic stroke and proximal arterial occlusion.
Read the detailed description
The current clinical trial is an investigator-initiated one, and it is conducted under the multi-center, randomized, open-label, prospective design. The subjects meeting inclusion/exclusion criteria will be assigned to the treatment group or the control group. The randomization ratio is 1:1. The subjects of the treatment group will receive a 2-day hypothermia therapy followed by the process of recovery of temperature within 30 hours (the recovery phase). After 3 months of the onset of symptoms, mRS scores are measured. This is followed by the closure of the clinical trial.
- Conditions
- Ischemic Stroke, Thrombolytic Therapy
- Being tested
- Arctic Sun, Standard treatment, Saline
- Keywords
- Therapeutic hypothermia
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arctic SunDevice
Also called Therapeutic hypothermia
- Induction phase: At a temperature of 4℃, a saline 500 mL or 1 L is intravenously administered. Arctic sun (surface freezing equipment) Target temperature: 35±0.5℃ Within 12 hours of the onset of symptoms, the therapeutic hypothermia is performed
- Maintenance phase:The use of bedside shivering assessment scale (BSAS) The use of Columbia anti-shivering protocol,Maintenance period: 48 hours
- Recovery phase:Rewarming velocity: 0.05~0.1℃ (within 30 hours)
Standard treatmentOther
- All the patients receive standard treatment modalities for stroke, which are applicable to the international treatment guidelines.
- In all the patients, neurological assessments and NIHSS scoring are performed on a daily basis for 4 days with the help of board-certified nurses or specialists in stroke.
- Blood pressure, respiratory rate and heart rate are measured at least once at a 4-hour interval for 4 days.
- Using an esophageal thermometer, the central temperature is measured at a 2-hour interval for 5 days.
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic hypothermia group | Experimental | Therapeutic hypothermia using surface cooling device (Arctic Sun) Stroke care based on international guidelines except therapeutic hypothermia using surface cooling device (Arctic Sun) Receives: Device: Arctic Sun; Drug: Saline |
| Control group | Other | Stroke care based on international guidelines Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable outcome
modified Rankin Scale of 0-2 points at 3 months
Measured: 3 months after symptom onset
mortality at 3 months
mortality at 3 months
Measured: 3 months after symptom onset
Secondary outcomes (2)
Improvements in neurological functions
Changes in the cerebral infarction lesions at 5~7 days
Measured: Volume change on diffusion lesion at 5~7 days
Symptomatic cerebral hemorrhage
deterioration in the National Institute of Health Stroke Scale score of ≥4 points with parenchymal hematoma type 2 documented by CT or MR image
Measured: within 5~7 days of symptom onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bard Medical Division C.R. Bard Inc
- Responsible party
- Principal investigator, Moon Ku Han, Seoul National University Hospital
- Investigators
- MOON-KU HAN, professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985060
- Sponsor's protocol ID
- HELMET ver1.1
- Acronym
- HELMET
- Status last verified
- Dec 2016
- First submitted
- 5 Dec 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Jeong JH, Hong JH, Sohn SI, Park H, Chang JY, Yum KS, Kang J, Han MK. Mild Hypothermia After Endovascular Treatment for Acute Ischemic Stroke: A Pilot Randomized Controlled Trial. Stroke. 2025 Nov;56(11):3100-3107. doi: 10.1161/STROKEAHA.124.049762. Epub 2025 Aug 12.
PubMed 40791183
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke; Prospective, Open, Randomized, Multicenter Phase II Study
- ClinicalTrials.gov ID
- NCT02985060
- Acronym / sponsor ID
- HELMET / HELMET ver1.1
- Conditions
- Ischemic Stroke, Thrombolytic Therapy
- Keywords
- Therapeutic hypothermia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Bard Medical Division C.R. Bard Inc
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 7 Dec 2016 (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.
To study safety and feasibility of mild therapeutic hypothermia after successful recanalization by mechanical endovascular treatment in patients with acute ischemic stroke and proximal arterial occlusion.
Detailed description
The current clinical trial is an investigator-initiated one, and it is conducted under the multi-center, randomized, open-label, prospective design. The subjects meeting inclusion/exclusion criteria will be assigned to the treatment group or the control group. The randomization ratio is 1:1. The subjects of the treatment group will receive a 2-day hypothermia therapy followed by the process of recovery of temperature within 30 hours (the recovery phase). After 3 months of the onset of symptoms, mRS scores are measured. This is followed by the closure of the clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic hypothermia group | Experimental | Device: Arctic Sun, Drug: SalineTherapeutic hypothermia using surface cooling device (Arctic Sun) Stroke care based on international guidelines except therapeutic hypothermia using surface cooling device (Arctic Sun) |
| Control group | Other | Other: Standard treatmentStroke care based on international guidelines |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who submitted a written informed consent prior to the participation in the current clinical trial (If the subjects have conditions that they cannot decide on study participation according to their own will, they would participate in the study after their legal representatives submitted a written informed consent form. During the period of study participation, if patients' medical conditions are improved, the written informed consent should be submitted again.)
- Patients with ischemic stroke attributed to carotid artery or middle cerebral artery occlusion achieved successful recanalization (TICI 2b or 3) immediately after endovascular treatment within 8 hours of symptom onset: Onset time was defined as the time when patients were lastly seen normal.
- Patients of both sexes aged between 18 and 80 years old
- NIHSS scores of 6-25 points at screening
- mRS 1 prior to the onset of disease, with proximal cerebral artery occlusion (e.g., those with middle cerebral or internal carotid artery)
Key exclusion criteria (15 listed)
- No evaluation for cranial artery before endovascular treatment
- Patient with emergent stenting insertion in intracranial or extracranial artery
- Transient ischemic attack or lacunar infarction
- Platelet counts < 75,000/mm3
- coagulopathy (INR spontaneously >1.5)
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 |
|---|---|---|
| Arctic SunAlso: Therapeutic hypothermia1. Induction phase: At a temperature of 4℃, a saline 500 mL or 1 L is intravenously administered. Arctic sun (surface freezing equipment) Target temperature: 35±0.5℃ Within 12 hours of the onset of symptoms, the therapeutic hypothermia is performed 2. Maintenance phase:The use of bedside shivering assessment scale (BSAS) The use of Columbia anti-shivering protocol,Maintenance period: 48 hours 3. Recovery phase:Rewarming velocity: 0.05~0.1℃ (within 30 hours) | Device | Therapeutic hypothermia group |
| Standard treatment1. All the patients receive standard treatment modalities for stroke, which are applicable to the international treatment guidelines. 2. In all the patients, neurological assessments and NIHSS scoring are performed on a daily basis for 4 days with the help of board-certified nurses or specialists in stroke. 3. Blood pressure, respiratory rate and heart rate are measured at least once at a 4-hour interval for 4 days. 4. Using an esophageal thermometer, the central temperature is measured at a 2-hour interval for 5 days. | Other | Control group |
| Saline | Drug | Therapeutic hypothermia group |
Primary outcome
Favorable outcome
Time frame: 3 months after symptom onset
modified Rankin Scale of 0-2 points at 3 months
mortality at 3 months
Time frame: 3 months after symptom onset
mortality at 3 months
2 secondary outcomes
Improvements in neurological functions
Time frame: Volume change on diffusion lesion at 5~7 days
Symptomatic cerebral hemorrhage
Time frame: within 5~7 days of symptom onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Derived from this study: PubMed 40791183Jeong JH, Hong JH, Sohn SI, Park H, Chang JY, Yum KS, Kang J, Han MK. Mild Hypothermia After Endovascular Treatment for Acute Ischemic Stroke: A Pilot Randomized Controlled Trial. Stroke. 2025 Nov;56(11):3100-3107. doi: 10.1161/STROKEAHA.124.049762. Epub 2025 Aug 12.
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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.
MOON-KU HAN, professor principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arctic Sun, Standard treatment and Saline in people with Ischemic Stroke and Thrombolytic Therapy, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 15 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 13 Dec 2016. 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 South Korea. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 MOON-KU HAN, professor (82-31-787-7464, mkhan@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable outcome (time frame: 3 months after symptom onset). 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?
On the ClinicalTrials.gov record for NCT02985060, which also lists 1 linked publication.
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 13 Dec 2016.