Phase
Condition
Occlusions
Chest Pain
Coronary Artery Disease
Treatment
Placebo
Anakinra
Clinical Study ID
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
All criteria need to be met.
Acute ST segment elevation myocardial infarction defined as:
chest pain, consistent with angina, within the prior 12 hours (for intermittentpain lasting more than 12 hours, the time from the when the pain became severeand constant);
ST segment elevation on ECG >1 mm in 2 or more anatomically contiguous leads;
Reperfusion strategy planned or completed (including percutaneous coronaryintervention or fibrinolysis)
Age >21 years.
Exclusion
Exclusion Criteria:
Subjects will not be eligible if they meet any of the following exclusion criteria.
Pregnancy;
Inability to obtain consent from patient;
History of prior STEMI or of systolic heart failure (LVEF<40%);
Contraindications to treatment with anakinra (i.e. prior allergic reaction toKineret® or E. coli derived products);
Duration of chest pain >12 hours at time of coronary artery catheterization (continuously - see exceptions in Inclusion Criteria) or coronary arteryintervention >12 hours earlier (see exceptions in Inclusion Criteria)[max durationof chest pain 24 hours];
Failed reperfusion strategy (unsuccessful percutaneous coronary intervention);
Need or plan for emergent cardiac surgery;
Anticipated inability to complete a cardiopulmonary exercise test (CPET) on atreadmill at follow up visit at 42 days (i.e. amputee, wheel-chair bound, severenon-cardiac illness limiting mobility).
Active infection (such as acute, i.e. COVID-19, or chronic/recurrent infectiousdisease i.e HBV, HCV, and HIV/AIDS-but excluding HCV+ patients with undetectableplasma RNA)
Acute or chronic inflammatory disease or immunosuppressive therapies (including oralcorticosteroids at a dose of prednisone equivalent of 0.5 mg/kg/day but notincluding inhaled or low dose oral corticosteroids or non-steroidalanti-inflammatory drugs).
Neutropenia (<1,500/mm3 or <1,000/mm3 in African-American patients).
Active acute or chronic psychiatric illness that in the opinion of the investigatormay prevent from complying with study instructions;
Stage V chronic kidney disease (estimated glomerular filtration rate 15mL/min/1.73m2 or less) or on renal-replacement therapy (a GFR ≥45 mL/min/1.73m2 isrequired for the cardiac magnetic resonance portion of the study);
Limited English Proficiency that in the opinion of the investigator may prevent fromunderstanding the content of the informed consent form and instructions during thetests required for the study.
Any comorbidity limiting survival or ability to complete the study.
Study Design
Study Description
Connect with a study center
University of Virginia
Charlottesville, Virginia 22908
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23298
United StatesSite Not Available
University of Virginia
Charlottesville 4752031, Virginia 6254928 22908
United StatesSite Not Available
Virginia Commonwealth University
Richmond 4781708, Virginia 6254928 23298
United StatesSite Not Available

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