Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-05 @ 9:28 PM
Study NCT ID:
NCT02985060
Status:
UNKNOWN
Last Update Posted:
2016-12-13
First Post:
2016-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke; Prospective, Open, Randomized, Multicenter Phase II Study
Status:
UNKNOWN
Status Verified Date:
2016-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HELMET
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: