Evaluation of Intracoronary Hyperoxemic Oxygen Therapy in Anterior Acute Myocardial Infarction Pa… (NCT02603835) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Intracoronary Hyperoxemic Oxygen Therapy in Anterior Acute Myocardial Infarction Patients (IC-HOT)
United States100 participantsStarted 2016-02
Plain-language summary
The primary objective of the study is to collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in treatment of anterior acute myocardial infarction (AMI) patients who have undergone successful percutaneous coronary intervention (PCI) with stenting within six hours of experiencing AMI symptoms.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. The subject must be ≥18 and ≤80 years of age.
✓. AMI must be anterior (ST-segment elevation \>1 mm in two or more contiguous leads between V1 and V4 or new left bundle branch block).
✓. Subject is experiencing clinical symptoms consistent with anterior AMI of ≤6 hour duration from time of symptom onset until admission to the emergency room.
✓. The subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB).
✓. Subject and his/her physician agree to all required follow-up procedures and visits.
✓. Based on coronary anatomy, PCI is indicated for revascularization of the culprit lesion(s) with use of a commercially available coronary stent (bare metal or drug-eluting, at operator discretion) in the LAD.
✓. The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery (other lesions in the LAD target vessel, including diagonal branches, may be treated if clinically indicated).
✓. Baseline (pre-PCI) TIMI flow grade 0, 1, 2, or 3 flow in the LAD.
Exclusion criteria
✕. Prior CABG surgery.
✕. Prior myocardial infarction, or known prior systolic dysfunction (known ejection fraction \<40% by any prior measure or regional wall motion abnormalities; this criterion does not include left ventricular dysfunction induced by the acute MI).
✕. Thrombolytic therapy administered for this STEMI.
✕. An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first 30 days post-enrollment.
✕. Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the anterior AMI.
✕. Subjects who have previously undergone an angioplasty or stenting procedure in the left anterior descending coronary artery.
✕. Subjects with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation (with or without papillary muscle rupture).
✕. Any contraindication to MRI imaging. This will include any of the following exclusions: