Myocardial Infarction Clinical Trial
Official title:
Hypothermia as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction
To evaluate and improve the safety and efficacy of hypothermia as an adjunctive therapy to percutaneous coronary intervention in patients with acute myocardial infarction.
Single-center, prospective, randomized, controlled clinical study involving at least 70
patients with up to 10 roll-in patients (for training purposes).
Male and female adults presenting with acute myocardial infarction may be eligible for this
research study. To qualify, patients must go to the Emergency Room within up to 6 hours of
onset of chest pain, present with anterior or inferior acute myocardial infarction with
elevation of the ST segment greater than 1mm in 2 or more contiguous leads in the anterior or
inferior wall and be eligible for the performance of a percutaneous intervention procedure.
The intervention will be intravascular hypothermia using Proteus System® as an adjunctive
method to percutaneous coronary intervention, adjunct hypothermia methods and parameters.
During the randomization phase, at least 70 patients who meet the eligibility criteria will
be randomly assigned to the 03 hour hypothermia group (percutaneous coronary intervention +
cooling), to the 01 hour hypothermia group (percutaneous coronary intervention + cooling) or
to the control group (percutaneous coronary intervention only) in a 1:1:1 ratio.
All patients receiving PCI + Cooling will also be randomized to groups A and B. Group A will
receive 1 liter of chilled normal saline (4°C) prior to PCI/reperfusion, and Group B will not
receive chilled normal saline (4°C), prior to PCI.
All patients included in the randomization phase will be included in the statistical
analysis.
Approximately 10 Roll-in patients may be enrolled at the center (for training purpose), with
anterior or inferior wall infarcts.
The primary endpoint will be reduction of the infarct size (%LV), studied with cardiac
magnetic resonance imaging (cMR) using late gadolinium enhancement 5 days after the AMI, and
30 days after the infarction.
The secundary endpoints will be
- incidence of major adverse cardiac events (MACE) or death within 30 days;
- resolution of the ST segment elevation after PCI;
- ejection fraction determined by cMR after 30 days.
- evaluation of adverse events potentially related to hypothermia and/or endovascular
cooling within 30 days.
- Differences in plaquelet aggregation during cooling and rewarming.
;
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