NCT03173313

COOL AMI EU Pivotal Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A)

COOL-AMI EU Pivotal Trial: A Multicenter, Prospective, Randomized-Controlled Trial to Assess the Safety and Effectiveness of Cooling As an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: ZOLL Circulation, Inc., USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is to evaluate the safety and effectiveness of therapeutic hypothermia, using the ZOLL Proteus IVTM System, as an adjunctive therapy for patients presenting with acute anterior myocardial infarction (AMI) and undergoing percutaneous coronary intervention (PCI).

Detailed description

A multicenter, prospective, interventional, randomized-controlled trial. Randomization will be in a 1:1 ratio, Test Arm (PCI + Cooling) or Control Arm (PCI alone) in up to 468 randomized subjects (234 subjects in each arm). Endpoint: Relative reduction of 20% in mean anterior myocardial infarct size as determined by Cardiac Magnetic Resonance (cMR) imaging at 4-6 days post infarct in the Test Arm (cooling + PCI) relative to the Control Arm (PCI only).

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Intravascular permissive hypothermia as an adjunct to PCI	Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI

Timeline

• Start date: 2017-04-14
• Primary completion: 2018-08-22
• Completion: 2019-08-31
• First posted: 2017-06-01
• Last updated: 2021-02-16
• Results posted: 2021-02-16

Locations

1 site across 1 country: Slovenia