Status:
COMPLETED
Anakinra to Prevent Adverse Post-infarction Remodeling (2)
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
American Heart Association
Conditions:
Acute Myocardial Infarction
Heart Failure
Eligibility:
All Genders
18-110 years
Phase:
PHASE2
Brief Summary
Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many patients die early during the course, and those who survive are at risk for dying late from adverse cardiac rem...
Detailed Description
Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many patients die early during the course, and those who survive are at risk for dying late from adverse cardiac rem...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with STEMI will be asked to enroll according to the following inclusion criteria:
- age \> 18 years,
- acute (\<12 h) onset of chest pain associated with ST segment elevation (\>2 mm) in 2 or more anatomically contiguous leads at ECG,
- and successful primary percutaneous coronary intervention.
- Exclusion criteria:
- inability to give informed consent,
- late presentation (\>12 h),
- unsuccessful revascularization procedure,
- hemodynamic instability including hypotension,
- prior Q-wave AMI,
- end-stage congestive heart failure (American Heart Association \[AHA\]/American College of Cardiology \[ACC\] class C-D, New York Heart Association IV), severe left ventricular dysfunction (EF\<20%),
- severe valvular heart disease,
- pregnancy, dye allergy or contraindications to cardiac angiography and/or magnetic resonance imaging, coagulopathy (INR\>1.5 or platelet count\<50000/mm3),
- recent (\<14 days) use of anti-inflammatory drugs (not including NSAIDs),
- chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), and malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study.
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01175018
Start Date
July 1 2010
End Date
December 1 2012
Last Update
May 23 2016
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298