Endothelial DysfunctionPhase 1/2CREDENTIALNCT01242306
Comparison of Endothelial Dysfunction (BMS vs SES) in the Same Patient With Multiple Coronary Artery Lesions
A Phase 1/2 study testing intracoronary infusion of acetylcholine in people with Endothelial Dysfunction, run by Azienda Ospedaliera San Camillo Forlanini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- intracoronary infusion of acetylcholine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2009to Dec 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- intracoronary infusion of acetylcholine
- Keywords
- endothelial dysfunction acetylcholine bms ses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracoronary infusion of acetylcholineDrug
Also called cypher coroflex
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.
| Study group | Role | What they receive |
|---|---|---|
| BMS arm | Placebo comparator | bare metal stent arm Receives: Drug: intracoronary infusion of acetylcholine |
| SES arm | Active comparator | sirolimus eluting stent arm Receives: Drug: intracoronary infusion of acetylcholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startMar 2009
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Camillo Forlanini
- Sponsor type
- University, hospital or other
- Investigators
- Violini Roberto, MD, Study chair, Azienda Ospedaliera San Camillo ForlaniniMischie Nicolae Alexandru, MD, Principal investigator, European Society of CardiologyNazzaro Marco, MD, Study director, Azienda Ospedaliera San Camillo Forlanini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242306
- Sponsor's protocol ID
- CREDENTIAL
- Acronym
- CREDENTIAL
- Status last verified
- Apr 2009
- First submitted
- 16 Nov 2010
- Last updated
- 17 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23359371
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01242306
- Acronym / sponsor ID
- CREDENTIAL / CREDENTIAL
- Conditions
- Endothelial Dysfunction
- Keywords
- endothelial dysfunction acetylcholine bms ses
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San Camillo ForlaniniUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMS arm | Placebo comparator | Drug: intracoronary infusion of acetylcholinebare metal stent arm |
| SES arm | Active comparator | Drug: intracoronary infusion of acetylcholinesirolimus eluting stent arm |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intracoronary infusion of acetylcholineAlso: cypher coroflexAcetylcholine 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. | Drug | BMS arm, SES arm |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2010.
- Derived from this study: PubMed 23359371Mischie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Violini Roberto, MD study chair
Azienda Ospedaliera San Camillo Forlanini
Mischie Nicolae Alexandru, MD principal investigator
European Society of Cardiology
Nazzaro Marco, MD study director
Azienda Ospedaliera San Camillo Forlanini
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing intracoronary infusion of acetylcholine in people with Endothelial Dysfunction, run by Azienda Ospedaliera San Camillo Forlanini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01242306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2010.