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UnknownNCT01789411

The European Collaborative Project on Inflammation and Vascular Wall Remodeling in Atherosclerosis - Intravascular Ultrasound Study

Status
Unknown
Phase
Study type
Observational
Enrollment
800 (estimated)
Sponsor
Erasmus Medical Center · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERDrawing blood samplesDrawing blood samples from the arterial sheath prior to the standard coronary angiography procedure
DEVICECoronary intravascular ultrasound imagingCoronary intravascular ultrasound imaging of a non-culprit coronary artery.
DEVICECoronary near-infrared spectroscopyNear-infrared spectroscopy imaging of a non-culprit coronary artery (in patient who are included in the AtheroRemo-NIRS substudy).

Timeline

Start date
2008-11-01
Primary completion
2013-12-01
First posted
2013-02-12
Last updated
2013-02-12

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT01789411. Inclusion in this directory is not an endorsement.