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

NCT01242306 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2010-11-17

No results posted yet for this study

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.

Conditions

  • Endothelial Dysfunction

Interventions

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.

Sponsors & Collaborators

  • Azienda Ospedaliera San Camillo Forlanini

    lead OTHER

Principal Investigators

  • Violini Roberto, MD · Azienda Ospedaliera San Camillo Forlanini

  • Mischie Nicolae Alexandru, MD · European Society of Cardiology

  • Nazzaro Marco, MD · Azienda Ospedaliera San Camillo Forlanini

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-11-30
Completion
2009-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01242306 on ClinicalTrials.gov