Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction

Korábbi kezelés

• Prior major cardiac surgery, including but not limited to coronary artery bypass graft surgery (CABG).
• Concurrent enrolment in another investigational device or drug trial, or less than 30 days or 5 half-lives of investigational device or drug (whichever is longer), since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). Patients who are participating in non-interventional, purely observational trials can be included.
• Known history of hypersensitivity to the investigational drug, or excipients, or do not want to be exposed to soy or egg (including products and derivatives).

Más betegség

• History or ECG evidence of myocardial infarction or cardiomyopathy.
• Known contraindication to CMR (e.g. pacemakers, cochlear implants, aneurism clips, claustrophobia, allergy to contrast medium).
• History of clinically significant renal impairment requiring dialysis or an estimated glomerular filtration rate <30 mL/min.
• Life expectancy of less than 1 year due to non-cardiac pathology in the opinion of the Investigator.
• Any condition or significant clinical abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study.

Egyéb

• Estimated or known body weight < 50 kg, > 120 kg at screening.

• Have provided informed consent.
• Male patients aged 40 to 75 years of age.- Female patients aged 55 to 75 years of age, or women aged 40 to 55 years that have no possibility of being pregnant.
• Patient presents with first-time STEMI, scheduled to undergo primary PCI within 6 h of symptom onset and anticipated door to balloon time < 2 h.
• In combination with symptoms consistent with acute MI, patient must demonstrate ST-elevation at the J-point in two contiguous leads.
• Hemodynamically stable including: systolic BP ≥ 90 mmHg, HR 50-120 bpm.
• Killip Class I or II.
• Oxygen saturation ≥ 92% on room air or low-flow oxygen.
• No ongoing VT/VF at enrolment.
• Male participants with female partners of child-bearing potential must be ready and able to use highly effective methods of birth control for at least 7 days following IP administration.