RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-05-24

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05177822

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.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Benjamin Van Tassell, PharmD

CONTACT

804-828-4583

bvantassell@vcu.edu

Principal Investigator

Benjamin Van Tassell, PharmD

PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Study Locations (Sites)

University of Virginia

Charlottesville, Virginia, 22908

United States

Virginia Commonwealth University

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

Benjamin Van Tassell, PharmD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

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

Study Start Date2022-05-24

Study Completion Date2027-12

Study Record Updates

Study Start Date2022-05-24

Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure