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临床试验/NCT03982901
NCT03982901已完成不适用

Effect of Mental Stress on Myocardial Perfusion and Myocardial Blood Flow in Women With Chest Pain and Coronary Artery Stenosis Less Than 50%

Guangdong Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2019年6月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
The MBF change during mental stress test

研究概览

简要总结

Mental stress-induced myocardial ischemia(MSIMI) has been recognized a significant clinical problem. Evidence has shown that individuals with MSIMI have 2 to 2.5 times higher risk to develop a major averse cardiovascular events over 3-5 years, compared to their counterparts who have no MSIMI. Nevertheless, investigations into the study of MSIMI among women who have chest pain but artery stenosis < 50% have been lacking. In this project, the investigators used positron emission tomography (PET) to evaluate perfusion defect during mental stress to diagnose MSIMI. Women with chest pain and coronary artery stenosis < 50% were included as the experimental group, age-matched healthy people as the control group, the aim of this study is to compare the incidence of MSIMI in the two groups. At the same time, the study also observe the change of MBF during mental stress and the relationship between MBF and MSIMI.

详细描述

The goals of this project are to assess MSIMI prevalence in chest pain women with coronary artery stenosis less than 50%, as compared to age matched healthy women, and the MBF change during mental stress and adenosine vasodilator stress by PET with N-13 ammonia . This study will also establish the methodology of echocardiography to diagnose MSIMI by comparing with PET. To evaluate the consistency of myocardial blood flow (MBF by PET-CT) and peripheral blood flow (PAT ratio by EndoPAT) during stress test. and to explore the pathogenesis of MSIMI from aspects of neuroendocrine mechanism, sex hormone level, humoral immunity index and proteome expression.

The stress testing will be conducted at the PET-CT and echocardiography unit of Guangdong Provincial People's Hospital. Following a 20-minute calibration-rest period, participants will be asked to complete a series of 3 consecutive mental stress tasks. The mental stress tests are embedded in the virtual reality device, and the subjects can carry out the mental stress test with the virtual reality device on their heads. (1) Stroop Color-Word test, is administered by computer on a video monitor. A word appeared in the middle of the screen-Red, Green, Yellow, or Blue-in one of these four colors. At the bottom of the screen the words Red, Green, Yellow, and Blue appeared with the font color not matching the word meaning. The participant is asked to match the color of the word in the middle of the screen with the meaning of the color word at the bottom by clicking on the correct option, which lasts about 4 minutes. and then (2) Public speaking with anger recall: during this test, patients will be asked to give a speech on a recent situation in which they experienced anger to an audience of three observers (doctors) after 1 minute of preparation. Prior to the speech, subjects are told that their speech will be evaluated on their description of the situation, as to what happened, what they thought, felt, what they did, and what happened as a result. If they run out of things to say, the research tech will prompt them with questions to elicit more content until the three minutes are up. and at last the (3) Mental arithmetic: during this test, patients will be asked to perform a series of serial subtractions beginning at a given number which will be different for each repeated test and will be chosen by the tester from a fixed list of various numbers, with encouragement to perform calculations as quickly as possible; Each mental stress lasts for 4 minutes, there is no rest between the two mental stress, and the whole process of mental stress is 12 minutes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The MBF change during mental stress test

时间窗: half an hour

The MBF change during mental stress test

MSIMI (Measures as perfusion deficit with mental stress test via PET-CT) prevalence in chest pain women with coronary artery stenosis less than 50%, as compared to age matched healthy women.

时间窗: half an hour

Percentage of participants wih an presence of mental stress-induced myocardial ischemia (MSIMI) during the 3 mental stressors. MSIMI is defined by the following: compared to rest, 1) Each myocardial segment was scored from 0 to 4, with 0 being normal, 1 possibly normal, 2 definitely abnormal, 3 severely abnormal, and 4 no perfusion. The investigators calculated summed scores in a conventional fashion, including a summed stress score, a summed rest score, and a summed difference score. A summed difference score ≥3 is typically used as evidence of MSIMI.

次要结局

  • The consistency of PET-CT myocardial scanning and color Doppler echocardiography (contrast echocardiography, spot tracking) for the diagnosis of MSIMI.(30 days)
  • Blood flow reserve in women with chest pain and coronary artery stenosis < 50% .(half an hour)
  • The difference of sex hormone level between MSIMI(+) group and MSIMI(-) group(1 hour)
  • The difference of proteome expression level between MSIMI(+) group and MSIMI(-) group.(2 days)
  • The consistency of myocardial blood flow (MBF by PET-CT) and peripheral blood flow (PAT ratio by EndoPAT) under pressure test.(2 hours)
  • The neuroendocrine change in MSIMI(+) group, as compared with MSIMI(-) group.(1 hour)
  • The difference of humoral immunity index level between MSIMI(+) group and MSIMI(-) group.(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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