The European Collaborative Project on Inflammation and Vascular Wall Remodeling in Atherosclerosis - Intravascular Ultrasound Study (AtheroRemoIVUS)
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|ClinicalTrials.gov Identifier: NCT01789411|
Recruitment Status : Unknown
Verified February 2013 by Patrick W. Serruys, Erasmus Medical Center.
Recruitment status was: Active, not recruiting
First Posted : February 12, 2013
Last Update Posted : February 12, 2013
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|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Other: Drawing blood samples Device: Coronary intravascular ultrasound imaging Device: Coronary near-infrared spectroscopy|
|Study Type :||Observational|
|Estimated Enrollment :||800 participants|
|Official Title:||The European Collaborative Project on Inflammation and Vascular Wall Remodeling in Atherosclerosis - Intravascular Ultrasound Study|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||December 2013|
Drawing blood samples. Coronary intravascular ultrasound imaging. Coronary near-infrared spectroscopy.
Other: Drawing blood samples
Drawing blood samples from the arterial sheath prior to the standard coronary angiography procedure
Device: Coronary intravascular ultrasound imaging
Coronary intravascular ultrasound imaging of a non-culprit coronary artery.
Device: Coronary near-infrared spectroscopy
Near-infrared spectroscopy imaging of a non-culprit coronary artery (in patient who are included in the AtheroRemo-NIRS substudy).
- Vulnerable plaque as determined by intravascular ultrasound [ Time Frame: cross-sectional (time of baseline coronary angiography, no follow-up) ]The primary objective is to correlate coronary plaque phenotype as determined by intravascular ultrasound with genetic profile and circulating biomarkers. Primary endpoint is the presence of vulnerable plaque as determined by intravascular ultrasound.
- Major adverse cardiac events [ Time Frame: 1-year follow-up ]The secondary objective is to assess the prognostic value of novel biomarkers and plaque phenotypes as determined by intravascular ultrasound and near-infrared spectroscopy. Secondary endpoint is 1-year incidence of major adverse cardiac events.
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- Patients of both sexes, more than 21 years old.
- Patients with stable angina pectoris (CCS Class 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or patients with documented silent ischemia or patients with an acute myocardial infarction (STEMI and NSTEMI).
- Patients eligible for coronary revascularization in the native coronary artery/arteries.
- Willing and able to comply with the specified follow-up evaluation.
- Written informed consent obtained.
- Flow-limiting stenosis (diameter stenosis ≥50% by QCA or visual estimate) that is held responsible for angina pectoris or acute coronary syndrome
- The study vessel has not undergone percutaneous coronary intervention in the last 8 months.
- Braunwald class IA, IIA, IIIA (angina caused by non-cardiac illness).
- Women who are pregnant or women of childbearing potential who do not use adequate contraception.
- Known allergies to aspirin, clopidogrel bisulfate (Plavix ®), Ticlopdine (Ticlid ®) heparin, stainless steel, copper or a sensitivity to contrast media which cannot be adequately pre-medicated.
- Previous participation in this study or participation in another study with any investigational drug or device within the past 30 days (study participation ends after completion of the final follow-up.)
- Life expectancy of less than one year or factors making clinical and/or angiographic follow-up difficult.
- Planned or being status post coronary bypass surgery.
- Planned major non-cardiac surgery.
- Impaired renal function (creatinine >2 mg/dl or >150 umol/L).
- The subject has a history of bleeding diathesis or coagulopathy.
- The subject suffered disabling stroke within the past year.
- 3-vessel coronary artery and/or Left main disease with > 50% stenosis.
- Minimal lumen diameter <2mm in the segments to be analyzed within the study vessel.
- Diameter Stenosis >70% or total occlusion of the study vessel.
- In case the study-vessel has been stented previously (>8 months ago), more than 1/3 proximal of the study vessel (at least 40mm in length) should be available for examination (i.e., outside the length of the stent plus 5mm proximal to the stent).
- Poor LV function as assessed by Echo or by Angiography.
- The proximal vessel is moderately to severely tortuous (moderate: 2 bends >75 degrees or one bend >90 degrees) in the segment(s) to be analyzed.
- Known tendency to coronary vasospasm.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789411
|Study Chair:||Patrick W Serruys, MD, PhD||Erasmus Medical Center|
|Responsible Party:||Patrick W. Serruys, MD, PhD, Erasmus Medical Center|
|Other Study ID Numbers:||
EMC MEC 2008-210
|First Posted:||February 12, 2013 Key Record Dates|
|Last Update Posted:||February 12, 2013|
|Last Verified:||February 2013|
Coronary Artery Disease
Arterial Occlusive Diseases