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出境医 / 临床实验 / Effect of Mental Stress on Myocardial Perfusion in Women (MS in women)

Effect of Mental Stress on Myocardial Perfusion in Women (MS in women)

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-Obstructive Coronary Atherosclerosis Diagnostic Test: Mental Stress Test Not Applicable

Detailed Description:

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Mental Stress on Myocardial Perfusion and Myocardial Blood Flow in Women With Chest Pain and Coronary Artery Stenosis Less Than 50%
Actual Study Start Date : June 18, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: women with chest pain
women with chest pain and coronary artery stenosis less than 50%
 Diagnostic Test: Mental Stress Test
In this study, we compare MSIMI prevalence in the two groups (chest pain group and no chest pain group). Each subject in both groups receive the same mental stress test process, and the mental stress test process have 3 consecutive stress tests, which including: Stroop Color-Word test; Public speaking with anger recall test and Mental arithmetic test.
Sham Comparator: healthy women
women without chest pain and coronary artery stenosis less than 50%
 Diagnostic Test: Mental Stress Test
In this study, we compare MSIMI prevalence in the two groups (chest pain group and no chest pain group). Each subject in both groups receive the same mental stress test process, and the mental stress test process have 3 consecutive stress tests, which including: Stroop Color-Word test; Public speaking with anger recall test and Mental arithmetic test.
Outcome Measures
Primary Outcome Measures :
  1. 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. [ Time Frame: 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.


  2. The MBF change during mental stress test [ Time Frame: half an hour ]
    The MBF change during mental stress test


Secondary Outcome Measures :
  1. Blood flow reserve in women with chest pain and coronary artery stenosis < 50% . [ Time Frame: half an hour ]
    Bood flow reserve of participants using Adenosine

  2. The consistency of PET-CT myocardial scanning and color Doppler echocardiography (contrast echocardiography, spot tracking) for the diagnosis of MSIMI. [ Time Frame: 30 days ]
    The consistency between PET-CT and Doppler echocardiography (contrast echocardiography, spot tracking) in diagnosing MSIMI

  3. The consistency of myocardial blood flow (MBF by PET-CT) and peripheral blood flow (PAT ratio by EndoPAT) under pressure test. [ Time Frame: 2 hours ]
    The consistency between myocardial blood flow and peripheral blood flow during mental stress test

  4. The neuroendocrine change in MSIMI(+) group, as compared with MSIMI(-) group. [ Time Frame: 1 hour ]
    The cause of MSIMI

  5. The difference of sex hormone level between MSIMI(+) group and MSIMI(-) group [ Time Frame: 1 hour ]
    The cause of MSIMI

  6. The difference of humoral immunity index level between MSIMI(+) group and MSIMI(-) group. [ Time Frame: 1 hour ]
    The cause of MSIMI

  7. The difference of proteome expression level between MSIMI(+) group and MSIMI(-) group. [ Time Frame: 2 days ]
    The cause of MSIMI


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

The inclusion criteria are as follows:

1) Women with chest pain and coronary artery stenosis < 50% 2) Participate in the trial voluntarily and sign the informed consent form; 3) older than 18 and less than 75 years old, female; 4) be able to cooperate with the completion of evaluation and inspection. Exclusion criteria.

  1. Chest pain caused by diseases other than the cardiovascular system such as Aortic dissection, Pulmonary embolism;
  2. Combined with pulmonary embolism;
  3. Combined with aortic dissection;
  4. A serious life-threatening arrhythmias;
  5. Combined with cardiomyopathy or severe valvular disease;
  6. New York Heart Association(NYHA) class IV;
  7. Recent myocardial infarction within 1 month;
  8. Combined with severe mental illness, such as schizophrenia, Active suicidal ideation etc.
  9. History of substance and alcohol abuse in the previous 12 months;
  10. Significant cardiac, pulmonary, metabolic, renal, hepatic disease, or malignancy, interfering with patient's participation in this study;
  11. Currently taking antidepressant or antianxiety medications within 1 month;
  12. Participated in other clinical trials within 3 months;
  13. Cognitive impairment or inability to cooperate with researchers.
Contacts and Locations

Locations
Layout table for location information
China, Guangdong
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Investigators
Layout table for investigator information
Study Chair: Qingshan Geng Guangdong Provincial People's Hospital
Tracking Information
First Submitted Date  ICMJE June 2, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date August 7, 2020
Actual Study Start Date  ICMJE June 18, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2019)
  • 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. [ Time Frame: 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.
  • The MBF change during mental stress test [ Time Frame: half an hour ]
    The MBF change during mental stress test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2019)
  • Blood flow reserve in women with chest pain and coronary artery stenosis < 50% . [ Time Frame: half an hour ]
    Bood flow reserve of participants using Adenosine
  • The consistency of PET-CT myocardial scanning and color Doppler echocardiography (contrast echocardiography, spot tracking) for the diagnosis of MSIMI. [ Time Frame: 30 days ]
    The consistency between PET-CT and Doppler echocardiography (contrast echocardiography, spot tracking) in diagnosing MSIMI
  • The consistency of myocardial blood flow (MBF by PET-CT) and peripheral blood flow (PAT ratio by EndoPAT) under pressure test. [ Time Frame: 2 hours ]
    The consistency between myocardial blood flow and peripheral blood flow during mental stress test
  • The neuroendocrine change in MSIMI(+) group, as compared with MSIMI(-) group. [ Time Frame: 1 hour ]
    The cause of MSIMI
  • The difference of sex hormone level between MSIMI(+) group and MSIMI(-) group [ Time Frame: 1 hour ]
    The cause of MSIMI
  • The difference of humoral immunity index level between MSIMI(+) group and MSIMI(-) group. [ Time Frame: 1 hour ]
    The cause of MSIMI
  • The difference of proteome expression level between MSIMI(+) group and MSIMI(-) group. [ Time Frame: 2 days ]
    The cause of MSIMI
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Mental Stress on Myocardial Perfusion in Women
Official Title  ICMJE Effect of Mental Stress on Myocardial Perfusion and Myocardial Blood Flow in Women With Chest Pain and Coronary Artery Stenosis Less Than 50%
Brief Summary 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.
Detailed Description

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Non-Obstructive Coronary Atherosclerosis
Intervention  ICMJE Diagnostic Test: Mental Stress Test
In this study, we compare MSIMI prevalence in the two groups (chest pain group and no chest pain group). Each subject in both groups receive the same mental stress test process, and the mental stress test process have 3 consecutive stress tests, which including: Stroop Color-Word test; Public speaking with anger recall test and Mental arithmetic test.
Study Arms  ICMJE
  • Experimental: women with chest pain
    women with chest pain and coronary artery stenosis less than 50%
    Intervention: Diagnostic Test: Mental Stress Test
  • Sham Comparator: healthy women
    women without chest pain and coronary artery stenosis less than 50%
    Intervention: Diagnostic Test: Mental Stress Test
Publications * Ma H, Guo L, Fei H, Yin H, Wang H, Bai B, Liu Y, Wang S, Geng Q, Jiang W. Assessing mental stress on myocardial perfusion and myocardial blood flow in women without obstructive coronary disease: protocol for a mechanistic clinical trial. BMJ Open. 2020 Dec 8;10(12):e038362. doi: 10.1136/bmjopen-2020-038362.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 9, 2019) 		126
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

The inclusion criteria are as follows:

1) Women with chest pain and coronary artery stenosis < 50% 2) Participate in the trial voluntarily and sign the informed consent form; 3) older than 18 and less than 75 years old, female; 4) be able to cooperate with the completion of evaluation and inspection. Exclusion criteria.

  1. Chest pain caused by diseases other than the cardiovascular system such as Aortic dissection, Pulmonary embolism;
  2. Combined with pulmonary embolism;
  3. Combined with aortic dissection;
  4. A serious life-threatening arrhythmias;
  5. Combined with cardiomyopathy or severe valvular disease;
  6. New York Heart Association(NYHA) class IV;
  7. Recent myocardial infarction within 1 month;
  8. Combined with severe mental illness, such as schizophrenia, Active suicidal ideation etc.
  9. History of substance and alcohol abuse in the previous 12 months;
  10. Significant cardiac, pulmonary, metabolic, renal, hepatic disease, or malignancy, interfering with patient's participation in this study;
  11. Currently taking antidepressant or antianxiety medications within 1 month;
  12. Participated in other clinical trials within 3 months;
  13. Cognitive impairment or inability to cooperate with researchers.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03982901
Other Study ID Numbers  ICMJE 2019298H(R3)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All data (including data dictionaries) from individuals consent to the present project, after de-identification, will be shared that include all been discussed in this article. Study protocol, statistical analysis plan, and analytic code are available for sharing. We anticipate data sharing will be ready 6 months after the publication of the primary end point of this project, and ending 36 months following article publication. Our data may be shared with investigators who provide a methodologically sound proposal with approval of an independent review committee. Proposals should be directed to gengqsh@163.net. To gain access, data requestors will need to sign a data access agreement with our institution. Data are available for 5 years at the data management center.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Responsible Party Guangdong Provincial People's Hospital
Study Sponsor  ICMJE Guangdong Provincial People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Qingshan Geng Guangdong Provincial People's Hospital
PRS Account Guangdong Provincial People's Hospital
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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