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Trial record 36 of 181 for:    Recruiting, Not yet recruiting, Available Studies | Chest pain

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

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ClinicalTrials.gov Identifier: NCT03982901
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Guangdong General Hospital

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.


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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 : May 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain Stress

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.




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982901


Contacts
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Contact: Qingshan Geng 13922205818 gengqingshan@gdph.org.cn

Locations
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China, Guangdong
Guangdong Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Qingshan Geng, MD,PhD         
Sponsors and Collaborators
Guangdong General Hospital
Investigators
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Study Chair: Qingshan Geng Guangdong Provincial People's Hospital

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Responsible Party: Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT03982901     History of Changes
Other Study ID Numbers: 2019298H(R3)
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guangdong General Hospital:
Stress
Ischemia
PET-CT
Additional relevant MeSH terms:
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Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Stress, Psychological
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Behavioral Symptoms