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

NCT01242306 | Completed Phase 1 DMC

• 1 other identifier: CREDENTIAL
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction

Keywords

endothelial dysfunction acetylcholine bms ses

Outcome Measures

Primary Outcomes (1)

• 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

  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

  6 months

Study Arms (2)

BMS arm

PLACEBO COMPARATOR

bare metal stent arm

Drug: intracoronary infusion of acetylcholine

SES arm

ACTIVE COMPARATOR

sirolimus eluting stent arm

Drug: intracoronary infusion of acetylcholine

Interventions

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.

Also known as: cypher coroflex

BMS arm; SES arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera San Camillo Forlanini: lead

Study Sites (1)

Azienda Ospedaliera San Camillo Forlanini

Roma, Roma, 00151, Italy

Location

Related Publications (1)

• 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.

  PMID: 23359371 DERIVED

Study Officials

• Violini Roberto, MD

  Azienda Ospedaliera San Camillo Forlanini

  STUDY CHAIR

• Mischie Nicolae Alexandru, MD

  European Society of Cardiology

  PRINCIPAL INVESTIGATOR

• Nazzaro Marco, MD

  Azienda Ospedaliera San Camillo Forlanini

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: November 17, 2010
• Study Start: March 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 17, 2010

Record last verified: 2009-04

Locations

IT (1)