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

NCT ID: NCT01242306

Last Updated: 2010-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-12-31

Brief 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

Keywords

endothelial dysfunction acetylcholine bms ses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BMS arm

bare metal stent arm

Group Type: PLACEBO_COMPARATOR

intracoronary infusion of acetylcholine

Intervention Type: 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.

SES arm

sirolimus eluting stent arm

Group Type: ACTIVE_COMPARATOR

intracoronary infusion of acetylcholine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

cypher coroflex

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera San Camillo Forlanini

OTHER

Sponsor Role: lead

Responsible Party

European Society of Cardiology

Principal Investigators

Violini Roberto, MD

Role: STUDY_CHAIR

Azienda Ospedaliera San Camillo Forlanini

Mischie Nicolae Alexandru, MD

Role: PRINCIPAL_INVESTIGATOR

European Society of Cardiology

Nazzaro Marco, MD

Role: STUDY_DIRECTOR

Azienda Ospedaliera San Camillo Forlanini

Locations

Azienda Ospedaliera San Camillo Forlanini

Roma, Roma, Italy

Countries

Italy

References

Mischie AN, Nazzaro MS, Fiorilli R, De Felice F, Musto C, Confessore P, Parma A, Boschetti C, Violini R. Head-to-head comparison of sirolimus-eluting stent versus bare metal stent evaluation of the coronary endothelial dysfunction in the same patient presenting with multiple coronary artery lesions: the CREDENTIAL study. Catheter Cardiovasc Interv. 2013 Sep 1;82(3):E184-91. doi: 10.1002/ccd.24844. Epub 2013 Mar 5.

Reference Type: DERIVED

PMID: 23359371 (View on PubMed)

Other Identifiers

CREDENTIAL

Identifier Type: -

Identifier Source: org_study_id