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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02509832

Enrollment

100

Registered

2015-07-28

Start date

2015-07-31

Completion date

2018-06-30

Last updated

2020-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

Therapeutic Hypothermia (TH), Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI)

Brief 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.

Interventions

DEVICECooling + PCI

Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI)

DEVICEPCI only

Standard of Care for PCI

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All Inclusion Criteria must be answered YES for subject to be eligible for trial Inclusion Criteria: 1. ≥ 18 years of age. 2. symptoms consistent with AMI (chest pain, unresponsive to nitroglycerin, ≥ 30 minutes and \< 6 hours. 3. Anterior MI with ST-segment elevation of 0.2 mV in two or more anterior contiguous precordial leads. 4. Eligible for PCI. 5. Opportunity for at least 10 minutes of cooling with the Proteus IVTM System prior to PCI. 6. Written, informed consent to participate in this clinical trial.

Exclusion criteria

All

Design outcomes

Primary

Measure	Time frame
Proportion of all subjects who complete the follow-up and cMR imaging requirements at 30-day follow up period	30 day

Secondary

Measure	Time frame
1. Anterior Infarct Size (IS) as assessed by Cardiac Magnetic Resonance (cMR) at 4 - 6 days following the index procedure for subjects in Test and Control Arms	4 - 6 days

Countries

Austria, Estonia, Hungary, Poland, Serbia, Slovenia, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026