Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure
Patients who have a heart attack are at high risk for future development of heart failure ('weakening of the heart'). The researchers believe that the reaction of the heart muscle to injury (inflammation) during a heart attack may be contributing to the risk of heart failure. The current study will test the ability of an anti-inflammatory medicine (anakinra) to block the inflammation in the body during and after a heart attack.
Conditions:
๐Ÿฆ  Heart Failure
๐Ÿ—“๏ธ Study Start (Actual) 24 May 2022
๐Ÿ—“๏ธ Primary Completion (Estimated) February 2027
โœ… Study Completion (Estimated) December 2027
๐Ÿ‘ฅ Enrollment (Estimated) 84
๐Ÿ”ฌ Study Type INTERVENTIONAL
๐Ÿ“Š Phase PHASE2
Locations:
๐Ÿ“ Charlottesville, Virginia, United States
๐Ÿ“ Richmond, Virginia, United States

๐Ÿ“‹ Eligibility Criteria

Description

    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 intermittent pain lasting more than 12 hours, the time from the when the pain became severe and constant);
    • * ST segment elevation on ECG \>1 mm in 2 or more anatomically contiguous leads;
    • * Reperfusion strategy planned or completed (including percutaneous coronary intervention or fibrinolysis)
    • * Age \>21 years.

    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 to Kineretยฎ 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 artery intervention \>12 hours earlier (see exceptions in Inclusion Criteria)\[max duration of chest pain 24 hours\];
    • * Failed reperfusion strategy (unsuccessful percutaneous coronary intervention);
    • * Need or plan for emergent cardiac surgery;
    • * Anticipated inability to complete a cardiopulmonary exercise test (CPET) on a treadmill at follow up visit at 42 days (i.e. amputee, wheel-chair bound, severe non-cardiac illness limiting mobility).
    • * Active infection (such as acute, i.e. COVID-19, or chronic/recurrent infectious disease i.e HBV, HCV, and HIV/AIDS-but excluding HCV+ patients with undetectable plasma RNA)
    • * Acute or chronic inflammatory disease or immunosuppressive therapies (including oral corticosteroids at a dose of prednisone equivalent of 0.5 mg/kg/day but not including inhaled or low dose oral corticosteroids or non-steroidal anti-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 investigator may prevent from complying with study instructions;
    • * Stage V chronic kidney disease (estimated glomerular filtration rate 15 mL/min/1.73m2 or less) or on renal-replacement therapy (a GFR โ‰ฅ45 mL/min/1.73m2 is required for the cardiac magnetic resonance portion of the study);
    • * Limited English Proficiency that in the opinion of the investigator may prevent from understanding the content of the informed consent form and instructions during the tests required for the study.
    • * Any comorbidity limiting survival or ability to complete the study.
Ages Eligible for Study: 21 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

๐Ÿ—“๏ธ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 December 2021
  • First Submitted that Met QC Criteria 14 December 2021
  • First Posted 5 January 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 May 2024
  • Last Update Posted 3 May 2024
  • Last Verified May 2024