Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure

Description

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

Heart Failure

Study Overview

Study Details

Study overview

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.

Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure: The Virginia - Anakinra Remodeling Trial 4

Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22908

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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 Kineret® 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 ≥45 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Virginia Commonwealth University,

Benjamin Van Tassell, PharmD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

2027-12