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Ultrasound protocol and quality control procedures in the European Lacidipine Study on Atherosclerosis (ELSA)
M Mercuri1, R Tang, R M Phillips
1Division of Vascular Ultrasound Research, Bowman Gray School of Medicine of Wake Forest University, Winston-Salem, NC, USA. Michele_Mercuri@medcenter-wpmail-wfu.edu
Insights
The ELSA trial compares Lacidipine to atenolol for atherosclerosis in patients with high blood pressure. Quality control ensures accurate ultrasound measurements of carotid artery thickness.
Area of Science:
- Cardiology
- Vascular Biology
- Medical Imaging
Background:
- Atherosclerosis progression in asymptomatic patients with hypertension requires effective monitoring.
- Carotid intima-media thickness (CIMT) is a key indicator of subclinical atherosclerosis.
- Calcium antagonists and beta-blockers are common treatments for hypertension, but their comparative effects on atherosclerosis are of interest.
Purpose of the Study:
- To compare the antiatherosclerotic effects of Lacidipine (calcium antagonist) versus atenolol (beta-blocker) in asymptomatic hypertensive patients.
- To evaluate changes in carotid intima-media thickness (CIMT) as a primary endpoint.
- To establish robust quality control measures for quantitative B-mode ultrasound imaging in a large-scale clinical trial.
Main Methods:
- The European Lacidipine Study on Atherosclerosis (ELSA) is a multinational, interventional clinical trial.
- 2300 cardiovascular asymptomatic patients with moderately high blood pressure were enrolled.
- Quantitative B-mode ultrasound imaging was used to measure CIMT in standardized carotid artery segments.
- Specific quality control protocols were implemented for instrumentation and ultrasound operators (sonographers and readers).
Main Results:
- The study is ongoing, and results are not yet available.
- Quality control data on measurement reproducibility are being collected.
- The ELSA trial aims to provide the largest prospective dataset on quality-controlled quantitative B-mode ultrasound imaging.
Conclusions:
- The ELSA trial is designed to yield significant insights into the antiatherosclerotic potential of Lacidipine compared to atenolol.
- The emphasis on rigorous quality control will enhance the reliability of ultrasound-based atherosclerosis assessment.
- Findings will contribute to understanding the management of atherosclerosis in hypertensive populations.
Abstract:
The European Lacidipine Study on Atherosclerosis (ELSA) is a multinational interventional clinical trial aimed at determining the antiatherosclerotic effects of Lacidipine, a calcium antagonist, when compared to atenolol, a beta-blocker, on the carotid arteries of 2300 cardiovascular asymptomatic patients with moderately high blood pressure. Quantitative B-mode ultrasound imaging is being used to measure the intima-media thickness of a standardized section of the carotid arteries including the distal common, bifurcation, and proximal internal carotids. Prospective investigations of large samples of population using ultrasonographic endpoints rely heavily on the precision and reproducibility of the method. Therefore, specific quality control protocols are required to determine and monitor cross-sectional and longitudinal stability of the measurement reproducibility. In ELSA, the ultrasound methodology was specifically designed to include a set of procedures to quality control the critical components of measurement variation including instrumentation, and ultrasound operators, i.e. sonographers and readers. The ELSA clinical trial will provide the largest set of prospective quality control data on the use of quantitative B-mode ultrasound imaging.