Effect of Mental Stress on Myocardial Perfusion in Women

NCT ID: NCT03982901

Last Updated: 2021-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-18
• Study Completion Date: 2021-04-29

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.

Conditions

Non-Obstructive Coronary Atherosclerosis

Keywords

Stress; Ischemia; PET-CT

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

women with chest pain

women with chest pain and coronary artery stenosis less than 50%

Group Type: EXPERIMENTAL

Mental Stress Test

Intervention Type: DIAGNOSTIC_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.

healthy women

women without chest pain and coronary artery stenosis less than 50%

Group Type: SHAM_COMPARATOR

Mental Stress Test

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qingshan Geng

Role: STUDY_CHAIR

Guangdong Provincial People's Hospital

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Countries

China

References

Liu Y, Jiang W, Wang H, Xu M, Liao Y, Zhou H, Bai B, Liu F, Yin H, Liu Q, Liang Y, Yu X, Guo L, Wang S, Ma H, Geng Q. Objective Ischemia, Subjective Angina, and Psychological Distress in Angina With No Obstructive Coronary Disease. J Am Heart Assoc. 2024 Aug 6;13(15):e034644. doi: 10.1161/JAHA.124.034644. Epub 2024 Jul 31.

Reference Type: DERIVED

PMID: 39082421 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33293388 (View on PubMed)

Other Identifiers

2019298H(R3)

Identifier Type: -

Identifier Source: org_study_id