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STUDY PROTOCOL
Year : 2017  |  Volume : 2  |  Issue : 3  |  Page : 59-65

Change in left ventricular global longitudinal peak strain for early diagnosis of high-risk coronary atherosclerotic heart disease in older adult patients: study protocol for a single-center diagnostic trial


1 Department of Ultrasound Medicine, Taihe Hospital (Affiliated Hospital of Hubei University of Medicine), Shiyan, Hubei Province, China
2 Department of Thoracic and Cardiovascular Surgery, Taihe Hospital (Affiliated Hospital of Hubei University of Medicine), Shiyan, Hubei Province, China

Correspondence Address:
Wen-jun Zhang
Department of Ultrasound Medicine, Taihe Hospital (Affiliated Hospital of Hubei University of Medicine), Shiyan, Hubei Province
China
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Source of Support: This study was supported by a grant from the Bureau of Science and Technology of Shiyan City of China, No. 15Y28., Conflict of Interest: None


DOI: 10.4103/2542-3975.216583

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Background and objective: Previous studies have demonstrated that tissue Doppler echocardiography and two-dimensional speckle tracking echocardiography are minimally invasive imaging methods used to screen for coronary atherosclerotic heart disease. However, they are not highly sensitive and specific for patients with suspected heart disease presenting with normal ventricular wall motion or for patients with early coronary heart disease. The newly emerging three-dimensional longitudinal strain imaging technology can overcome these shortcomings and has become a relatively mature technique for quantitative assessment of myocardial function. The left ventricular global longitudinal peak strain (LVGLPS) measured by three-dimensional longitudinal strain imaging technology contributes to early diagnosis of high-risk coronary atherosclerotic heart disease. Design: Single-center, open-label, diagnostic trial. Methods: Three hundred older adult patients with suspected coronary atherosclerotic heart disease receiving treatment from January 2013 to December 2017 at the Department of Ultrasound Medicine, Taihe Hospital of China, are being included in this study. These patients will be divided into three groups: low-risk group (n = 100; ≥ 70* diameter stenosis in one or two branches of the right main coronary artery and the left circumflex artery), high-risk group (n = 100; ≥ 50* diameter stenosis in the left main coronary artery or ≥ 70* diameter stenosis in the left anterior descending branch), and control group (n = 100; < 50* diameter stenosis in the main coronary arteries and all branches). All patients will undergo conventional echocardiography followed by three-dimensional longitudinal strain imaging to measure the LVGLPS. The LVGLPS will be compared among the three groups. Outcome measures: The primary outcome measure is the sensitivity of the LVGLPS for prediction of coronary atherosclerotic heart disease. The secondary outcome measures are: (1) the specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, and accuracy rate of the LVGLPS for prediction of coronary atherosclerotic heart disease; (2) change in the LVGLPS; (3) change in conventional echocardiography parameters; and (4) change in the receiver operating characteristic curve for prediction of high-risk coronary atherosclerotic heart disease using the LVGLPS. Discussion: The findings from this study will help to confirm that three-dimensional longitudinal strain imaging technology is highly sensitive and specific for patients with abnormal coronary arteries with suspected coronary heart disease but who present with normal ventricular wall motion. The change in the LVGLPS contributes to early diagnosis of high-risk coronary atherosclerotic heart disease in older adult patients. This helps clinicians to diagnose early coronary heart disease and take timely strategies to avoid serious cardiovascular events as much as possible. Ethics and dissemination: This study will be performed in accordance with the Declaration of Helsinki. All patients are informed of the study protocol and procedure and provide written informed consent. This trial was approved by Taihe Hospital (Affiliated Hospital of Hubei University of Medicine) (approval number: ethics No. 2013(03)) in January 2013. Participant recruitment and data collection began in January 2013 and will continue through December 2017. Outcome measure analysis will be performed and the trial will be completed in January 2018. Results will be disseminated through presentations at scientific meetings and publications in peer-reviewed journals. Trial registration: This trial was registered with the Chinese the Clinical Trial Registry (registration number: ChiCTR-DDD-17012839).


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