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Centralized echocardiogram quality control in a multicenter study of regression of left ventricular hypertrophy in
Insights
Centralized echocardiographic quality control in the LIVE study proved feasible and useful for hypertension research. It helped avoid unquantifiable echocardiograms and overestimation of left ventricular mass index in patients with left ventricular hypertrophy.
Area of Science:
- Cardiology
- Hypertension Research
- Medical Imaging Quality Control
Background:
- Left ventricular hypertrophy (LVH) is a significant complication of hypertension.
- Multicenter studies require robust quality control for echocardiographic data.
- The LIVE study investigates LVH regression in hypertensive patients.
Purpose of the Study:
- To assess the feasibility and utility of centralized echocardiographic quality control.
- To ensure the accuracy and reliability of echocardiographic measurements in a multicenter setting.
- To improve the quality of data used in studies of hypertension and LVH regression.
Main Methods:
- Implementation of a centralized evaluation committee for echocardiogram review.
- Validation of prestudy echocardiograms and ongoing quality control of videotapes.
- Randomized blinded analysis of echocardiographic data by the centralized committee.
- Comparison of investigator and centralized evaluation committee calculations of left ventricular mass index.
Main Results:
- A significant percentage of baseline (27%) and postinclusion (22%) echocardiograms required rejection or repetition due to quality issues.
- A strong correlation (r = 0.76, P < 0.001) was found between investigator and centralized evaluation committee measurements of left ventricular mass index.
- Investigator calculations consistently showed higher values for left ventricular mass index compared to centralized evaluations.
Conclusions:
- Real-time, centralized echocardiographic reading is feasible and beneficial for multicenter studies.
- Centralized quality control effectively prevents unquantifiable echocardiograms and overestimation of left ventricular mass index.
- This quality control method is recommended for future multicenter studies on LVH regression in hypertension.
Objective:
To test the feasibility and utility of instituting centralized echocardiographic quality control during a multicenter study of regression of left ventricular hypertrophy in hypertension.
Design And Methods:
The LIVE (Left Ventricular Hypertrophy: Indapamide Versus Enalapril) study is an ongoing multicenter, double-blind, controlled study of regression of echocardiographic left ventricular mass index in hypertensive patients with left ventricular hypertrophy (left ventricular mass indexes > 100 g/m2 for women and > 120 g/m2 for men) treated for 1 year with 1.5 mg indapamide sustained-release coated tablets versus 20 mg enalapril. A centralized evaluation committee has validated a prestudy sample echocardiogram from each center, and is now reviewing all videotapes recorded during this study for quality control; final results will be based on a further randomized blinded analysis by this centralized evaluation committee.
Results:
Since December 1994, 878 patients have been preselected (videoechocardiographic recordings sent for assessment), 645 selected (videoechocardiographic recordings validated), and 576 randomly allocated to treatment. After preliminary quality control, 27% (233) of baseline echocardiograms were rejected by our centralized evaluation committee, and 22% (142) of postinclusion echocardiographic measurements had to be repeated, mainly because they were of poor echogenic quality. Analysis of approved baseline echocardiograms for the first 274 randomly allocated patients with digitized data showed that there was a significant correlation between centralized evaluation committee and investigator calculations of left ventricular mass index (r = 0.76, P < 0.001), with consistently higher values for investigator calculations, independently of level of left ventricular mass index (correlation between difference and mean of investigator and centralized evaluation committee measurements, r = 0.08, P = 0.28). The mean difference was 8 +/- 20 g/m2 (P < 0.001).
Conclusion:
Early results of the LIVE study quality control showed that real-time 'live', centralized echocardiographic reading was not only feasible, but also useful for avoiding unquantifiable echocardiograms and overestimation of left ventricular mass index. Thus, real-time, centralized echocardiographic quality control should be recommended for multicenter studies of regression of left ventricular hypertrophy.