Circulating angiopoietins-1 and -2, angiopoietin receptor Tie-2 and vascular endothelial growth factor-A as biomarkers of acute myocardial infarction: a prospective nested case-control study.

Background: Angiogenesis is up-regulated in myocardial ischemia. However, limited data exist assessing the value of circulating angiogenic biomarkers in predicting future incidence of acute myocardial infarction (AMI). Our aim was to examine the association between circulating levels of markers of angiogenesis with risk of incident acute myocardial infarction (AMI) in men and women.

The VIVA trial: Vascular endothelial growth factor in Ischemia for Vascular Angiogenesis.

Background: Recombinant human vascular endothelial growth factor protein (rhVEGF) stimulates angiogenesis in animal models and was well tolerated in Phase I clinical trials. VIVA (Vascular endothelial growth factor in Ischemia for Vascular Angiogenesis) is a double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of intracoronary and intravenous infusions of rhVEGF.

Methods And Results: A total of 178 patients with stable exertional angina, unsuitable for standard revascularization, were randomized to receive placebo, low-dose rhVEGF (17 ng x kg(-1) x min(-1)), or high-dose rhVEGF (50 ng x kg(-1) x min(-1)) by intracoronary infusion on day 0, followed by intravenous infusions on days 3, 6, and 9.

Recombinant tissue plasminogen activator (alteplase) for restoration of function to occluded central venous catheters in pediatric patients.

Purpose: To evaluate the safety and efficacy of alteplase for restoring function to occluded central venous catheters in a pediatric population.

Patients And Methods: A phase III, open-label, single-arm, multicenter trial was performed in 995 adult and pediatric patients with dysfunctional nondialysis catheters and ports. This report is a subset analysis of subjects between 2 and 18 years of age (N = 122) who were enrolled in the study.

Treatment of occluded central venous catheters with alteplase: results in 1,064 patients.

Purpose: Thrombosis of central venous access devices (CVADs) is a relatively frequent complication. Alteplase (tissue plasminogen activator) has been used to salvage dysfunctional devices. The purpose of this study was to analyze the safety and efficacy of alteplase after administration of a maximum of two 2-mg/2-mL doses to thrombosed CVADs.

A target-mediated model to describe the pharmacokinetics and hemodynamic effects of recombinant human vascular endothelial growth factor in humans.

Background: The Vascular Endothelial Growth Factor (VEGF) in Ischemia for Vascular Angiogenesis (VIVA) trial was a double-blind, placebo-controlled, phase II clinical trial designed to evaluate the safety, efficacy, and pharmacokinetics of combined intracoronary and intravenous infusions of recombinant human vascular endothelial growth factor (rhVEGF(165)) for therapeutic angiogenesis. This study describes the use of a mechanism-based model to characterize the nonlinear kinetics observed after intravenous administration of rhVEGF(165). The model predicts that rhVEGF(165) distribution occurs through both saturable binding to high-affinity receptors and reversible interactions with low-affinity binding sites.

Safety and efficacy of alteplase for restoring function in occluded central venous catheters: results of the cardiovascular thrombolytic to open occluded lines trial.

Purpose: To evaluate the safety and efficacy of alteplase (TPA) for restoring function to occluded central venous catheters (CVCs).

Patients And Methods: The study design was a phase III, open-label, single-arm multicenter trial. Subjects with occluded, nondialysis CVCs were enrolled.