None listed
Conditions
Brief summary
The aim of treatment in a heart attack is to open the blocked coronary vessel causing the heart attack and return normal blood flow to the heart muscle as soon as possible. Despite this, many patients can suffer damage to the heart muscle. Hypothermia or cooling is predicted to reduce the extent of the heart muscle damage. Cooling fluid is infused via a catheter and delivered to the arteries that supply blood to the heart. This slows the heart muscle activity and reduces the amount of blood supply required for heart function. This cooling procedure is also proposed to help in the same way when normal blood flow is returned to the heart.
Interventions
A cooling solution ( Sterile Ringers Lactate cooled to 0 degrees C and 10 degrees C) will be stored at this temperature (monitored fridge temp) and then transfered to an ice bath just before delivery to the patient. It will be given via infusion through a line set connected to the aspiration catheter and delivered directly into the coronary artery at a rate of 5.0ml +/- 2.5ml for a minimum of 5 minutes. This will occur before and after the thrombus has been removed.
Sponsors
Prospex Medical III Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria Patients who meet the following criteria may be included: 1. Age > then or = to 18 years 2. The patient (or next-of-kin or legal representative) provided written informed consent. 3. Clinical symptoms of ongoing ischemic chest pain and 12-lead ECG confirmation of acute STEMI, as defined by the following ECG criteria present upon arrival to the PCI lab: a. Anterior infarct: ST-segment elevation >0.2mV measured 0.08 sec after the J point in 2 or more anatomically contiguous precordial leads, V1 - V6; and/or >0.1mV in leads I, AVL. OR b. Higher-risk inferior infarct: ST elevation >0.2mV measured 0.08 sec after the J point in 2 or more anatomically contiguous inferior leads II, III, AVF, and ST depression>0.1mV in 2 or more contiguous anterior leads, 4. Present to the study PCI lab within eight (8) hours of the onset of acute cardiac ischemic symptoms (such as chest pain or pressure, arm or jaw pain, dyspnea). 5. Be a candidate for primary PCI and have PCI planned as the immediate intervention. 6. Be willing and able to comply with study procedures, including returning for the cardiac MRI scan at 3+/-1 days post-procedure and be available for additional follow up. 7. Target coronary artery is completely or nearly completed occluded at angiography prior to PCI (TIMI 0 or 1 flow).
Exclusion criteria
Exclusion Criteria Patients who meet any one of these criteria will be excluded from the investigation: 1. Is or may be pregnant. 2. Prior myocardial infarct in the same coronary distribution 3. Known pre-existing LV dysfunction (LVEF< 40%) 4. Administration of a thrombolytic agent for the qualifying MI 5. History of mental illness 6. Clinical suspicion of a non-thrombotic cause for ST-segment elevation (e.g., pericarditis, vasospasm, takotsubo cardiomyopathy, illicit drug use) 7. Allergy or contraindication to heparin, aspirin or thienopyridines 8. Requires an immediate surgical or procedural intervention other than PCI (e.g. CABG) 9. Presents in cardiogenic shock 10. Has undergone at least 10 minutes of cardiopulmonary resuscitation (CPR) prior to presentation to the PCI facility, or have ongoing ventricular arrhythmias 11. History of surgical coronary artery revascularization (e.g. CABG) 12. Active bleeding, coagulopathy within previous 3 months 13. Known significant renal disease (on dialysis, post renal transplant or eGFR<30), known severe hepatic failure (e.g., cirrhosis, or acute hepatitis) 14. Serious concurrent medical condition likely to result in death during the next 12 months. 15. Contraindication to MRI (e.g., cardiac pacemaker, ICD, nerve stimulator, brain aneurysm clips, cochlear implants, claustrophobia) 16. Participation in another investigational clinical research study that has not reached its primary endpoint 17. The investigator determines that a patient is not a good candidate for the study despite having met all the eligibility criteria. 18. TIMI 2 or 3 flow in the target coronary artery
Outcome results
None listed