Intracoronary Cooling (Evaluation of Outcomes) before Angioplasty Revascularisation in ST Elevation Myocardial Infarctio

Not Applicable

• Conditions: ST Elevation Myocardial Infarction; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12613000242729
• Lead Sponsor: Prospex Medical III Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified