The European Collaborative Project on Inflammation and Vascular Wall Remodeling in Atherosclerosis - Intravascular Ultrasound Study (AtheroRemoIVUS)
The AtheroRemo-IVUS study aims to investigate the relation of coronary plaque phenotype and vulnerability as determined by intravascular ultrasound and near infrared spectroscopy with genetic profile and novel circulating biomarkers. AtheroRemo-IVUS is a prospective, observational, cohort study of patients who underwent coronary catheterization for acute coronary syndrome or stable angina pectoris. Prior to the catheterization procedure, blood samples were drawn for biomarker measurements and genetic analyses. Subsequent to the catheterization procedure, intravascular ultrasound is performed in a non-culprit coronary artery. In patients who are also participating in the AtheroRemo-NIRS substudy, near-infrared spectroscopy is additionally performed in the same non-culprit vessel. Primary endpoint is the presence of vulnerable plaque as determined by intravascular ultrasound. Secondary endpoint is long-term incidence of major adverse cardiac events. Results from AtheroRemo-IVUS are expected to improve our knowledge on the role of genetic profile and inflammation in the development of atherosclerosis and vulnerable plaques. Furthermore, novel biomarkers and intracoronary imaging techniques will be validated in this study.
Coronary Artery Disease
Other: Drawing blood samples
Device: Coronary intravascular ultrasound imaging
Device: Coronary near-infrared spectroscopy
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The European Collaborative Project on Inflammation and Vascular Wall Remodeling in Atherosclerosis - Intravascular Ultrasound Study|
- Vulnerable plaque as determined by intravascular ultrasound [ Time Frame: cross-sectional (time of baseline coronary angiography, no follow-up) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
Arterial blood samples
|Study Start Date:||November 2008|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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 procedureDevice: 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789411
|Study Chair:||Patrick W Serruys, MD, PhD||Erasmus MC|