NCT01242306

Comparison of Endothelial Dysfunction (BMS vs SES) in the Same Patient With Multiple Coronary Artery Lesions

Head-to-Head Comparison of Endothelial Dysfunction (Bare Metal Stent vs Sirolimus Eluting Stent) in the Same Patient With Multiple Coronary Artery Lesions

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Azienda Ospedaliera San Camillo Forlanini · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomised study to compare the endothelial dysfunction of BMS vs SES, both implanted in the same patient with multiple de novo coronary artery lesions undergoing elective PCI. The primary end point will be the evaluation of endothelial dysfunction at 6 months follow-up by measuring the change in vessel diameter in 5 points of the stent and peri-stent site after infusion of acetylcholine.

Detailed description

This prospective, randomised study compares the endothelial dysfunction of BMS vs SES, both implanted in the same patient with multiple de novo coronary artery lesions undergoing elective PCI. From february 2009 to may 2009 we aim to enroll 20 patients with at least two de novo significant angiographic stenoses in different coronary segments who will have similar diameter and length. The primary end point will be the evaluation of endothelial dysfunction at 6 months follow-up by measuring the change in vessel diameter in 5 points of the stent and peri-stent site after infusion of acetylcholine.

Conditions

• Endothelial Dysfunction

Interventions

Type	Name	Description
DRUG	intracoronary infusion of acetylcholine	Acetylcholine will be infused at a concentration of 140 microg/minute, over a period of 2 minutes, yielding estimated intracoronary concentrations of 10(-5)mol/L, with the assumption of a flow rate of 80mL/min). All infusions will be delivered at a constant rate using an infusion pump. Subsequently, in order to evaluate the endothelium-independent vasomotor response, 2mg of isosorbide dinitrate or bolus 250microg of nitroglycerine will be infused by intracoronary bolus in all subjects. The response to nitrate will be recorded 1 minute after the bolus. A 3-min period will be allowed to elapse between each drug infusion.

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2010-11-17
• Last updated: 2010-11-17

Locations

1 site across 1 country: Italy