Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure (NCT05177822) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure
United States84 participantsStarted 2022-05-24
Plain-language summary
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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 chro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.