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

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.

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Key information

Conditions

Endothelial Dysfunction

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Azienda Ospedaliera San Camillo Forlanini

Roma, 00151, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

stable angina pectoris
at least two significant angiographic stenoses in different native coronary vessels or in the same vessel but two different ramifications with similar diameter
non-surgical patients

Exclusion criteria

acute coronary syndromes
myocardial infarction within 3 months from event
clinical or angiographic coronary vasospasm
coronary angiographic findings of a fresh thrombus in the initial angiography (filling defect proximal to or involving the stenosis)
coronary anatomy unsuitable for for intracoronary acetylcholine testing (left main coronary artery disease >30%, surgical three vessel disease or other anatomical considerations that make it unsafe to perform intracoronary studies)
progression of lesions or development of de novo lesions in nontarget lesions or vessels on follow-up angiography
patients with a vessel diameter < 2,50 mm and length lesions <10 and >30 mm.
patients with vessel diameter difference (SES vs BMS) >0,5mm and length difference of the stenosis >50%
lesions treated with balloon injury <10 mm or >50 mm in length
severe left ventricular (LV) systolic dysfunction
bifurcation/ostial
presence of an unhealed dissection identified by intravascular ultrasound (IVUS) performed at the end of the study.
angiographic restenosis in follow-up angiography
patients with severe risk factors for endothelial dysfunction: severe renal failure, life expectancy less than 1 year, uncontrolled diabetes, uncontrolled hypertension (systolic blood pressure >180mmHg), currently smoking, uncontrolled hypercholesterolemia (total cholesterol >240mg/dl)
any contraindication/nontolerance to the use of aspirin, heparin and/or clopidogrel
lack of consent to participate

Treatment and study plan

intracoronary infusion of acetylcholine

Drug

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.

Other names: cypher coroflex

Primary outcomes

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

Time frame: 6 months

evaluation of change in vessel diameters (vasoconstriction or vasodilatation) in proximal and distal stent territories, after intracoronary acetylcholine infusion, having as reference the baseline diameters, for the BMS artery vs the SES artery

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera San Camillo Forlanini

Other

Registry information

Official study title

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

Acronym: CREDENTIAL

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Nov 17, 2010
Registry last updated: Nov 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed