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

This study has been completed.
Sponsor:
Information provided by:
Azienda Ospedaliera San Camillo Forlanini
ClinicalTrials.gov Identifier:
NCT01242306
First received: November 16, 2010
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Endothelial Dysfunction
 Drug: intracoronary infusion of acetylcholine
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Head-to-Head Comparison of Endothelial Dysfunction (Bare Metal Stent vs Sirolimus Eluting Stent) in the Same Patient With Multiple Coronary Artery Lesions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera San Camillo Forlanini:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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


Enrollment: 25
Study Start Date: March 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: BMS arm
bare metal stent arm
 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.
Other Name: cypher coroflex
Active Comparator: SES arm
sirolimus eluting stent arm
 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.
Other Name: cypher coroflex

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242306

Locations
Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy, 00151
Sponsors and Collaborators
Azienda Ospedaliera San Camillo Forlanini
Investigators
Study Chair: Violini Roberto, MD Azienda Ospedaliera San Camillo Forlanini
Principal Investigator: Mischie Nicolae Alexandru, MD European Society of Cardiology
Study Director: Nazzaro Marco, MD Azienda Ospedaliera San Camillo Forlanini
  More Information

No publications provided

Responsible Party: Mischie Nicolae Alexandru, European Society of Cardiology
ClinicalTrials.gov Identifier: NCT01242306     History of Changes
Other Study ID Numbers: CREDENTIAL
Study First Received: November 16, 2010
Last Updated: November 16, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera San Camillo Forlanini:
endothelial dysfunction acetylcholine bms ses

Additional relevant MeSH terms:
Acetylcholine
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013