Effect of Intravenous Immunglobulin (IVIG) After Myocardial Infarction

This double-blind placebo-controlled study represents a new approach to cardiovascular disease. The project deals with unresolved issues in the intersection between cardiology, immunology and molecular biology.

IVIG/placebo will be given as an induction therapy for 5 days and thereafter as monthly infusions for 5 months. Change in left ventricular remodeling will be assessed at baseline, and 6 and 12 months with MRI and echocardiography.

The objectives are:

• The primary objective of this study is to evaluate the effect on IVIG on LV remodeling and function: LV remodeling will be evaluated with magnetic resonance imaging (MRI) which offers an unsurpassed precision in the measurements of heart volumes and function. End points will be LV-end systolic and diastolic volume (LVESV, LVEDV), regional wall motion score index (WMSI), and LV-ejection fraction (LV-EF).
• The secondary objective of this study is to evaluate the effect on IVIG on the myocardial marker B-Type Natriuretic Peptide (BNP). BNP is a sensitive marker of the degree of HF besides being a prognostic indicator 18-20.
• The tertiary objective of this study is to evaluate the effect on IVIG on:

a. Quality of life. b. Effect on New York Heart Association (NYHA) functional class. c. Effect on immunological variables. i. Inflammatory cytokines such as TNF-alpha, IL-6, IL-18. ii. Anti-inflammatory cytokines such as IL-10 and transforming growth factor beta iii. Chemokines such as monocyte chemoattractant protein 1, IL-8 and CCL21. iv. Regulators of hypertrophy such as matrix metalloproteinases, their endogenous inhibitors (i.e., TIMPs) and procollagen III N-terminal.

d. Effect on neurohormones. e. Withdrawals. f. Side effects.

Inclusion criteria

• Age of 18-80 years
• Have a recent MI (<5days)
• Have ASAT >100 U/L or CKMB > 50 U/L.
• Have LVEF <40%.
• Are on optimal medical treatment and considered unsuitable for surgical intervention.

Exclusion criteria

• Evidence of unstable disease, concomitant ischemia or unstable angina during the hospitalization.
• Significant concomitant disease such as infections, pulmonary disease or connective tissue disease.
• Participating in other studies.
• Inability to participate.
• Diseases that require surgery.
• Planned revascularisation.
• Known hypersensitivity to IVIG.