Trials / Completed
CompletedNCT02509832
COOL AMI EU Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction
COOL-AMI EU PILOT TRIAL: A Multicenter, Prospective, Randomized Controlled Trial To Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With ACUTE MYOCARDIAL INFARCTION
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- ZOLL Circulation, Inc., USA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute Myocardial Infarction. Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.
Detailed description
Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cooling + PCI | Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) |
| DEVICE | PCI only | Standard of Care for PCI |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2018-03-01
- Completion
- 2018-06-01
- First posted
- 2015-07-28
- Last updated
- 2020-11-25
Locations
13 sites across 8 countries: Austria, Estonia, Hungary, Poland, Serbia, Slovenia, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT02509832. Inclusion in this directory is not an endorsement.