Non-Obstructive Coronary AtherosclerosisMS in womenNCT03982901
Effect of Mental Stress on Myocardial Perfusion in Women
A study testing Mental Stress Test in people with Non-Obstructive Coronary Atherosclerosis, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Non-Obstructive Coronary Atherosclerosis
- What is being tested?
- Mental Stress Test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2019to 29 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
The inclusion criteria are as follows:
- 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.
- Chest pain caused by diseases other than the cardiovascular system such as Aortic dissection, Pulmonary embolism;
- Combined with pulmonary embolism;
- Combined with aortic dissection;
- A serious life-threatening arrhythmias;
- Combined with cardiomyopathy or severe valvular disease;
- New York Heart Association(NYHA) class IV;
- Recent myocardial infarction within 1 month;
- Combined with severe mental illness, such as schizophrenia, Active suicidal ideation etc.
- History of substance and alcohol abuse in the previous 12 months;
- Significant cardiac, pulmonary, metabolic, renal, hepatic disease, or malignancy, interfering with patient's participation in this study;
- Currently taking antidepressant or antianxiety medications within 1 month;
- Participated in other clinical trials within 3 months;
- Cognitive impairment or inability to cooperate with researchers.
Trial locations and contacts
1 site in 1 country.
About this study
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%
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.
Read the 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
- Being tested
- Mental Stress Test
- Keywords
- Stress, Ischemia, PET-CT
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Stress TestDiagnostic 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 group | Role | What they receive |
|---|---|---|
| women with chest pain | Experimental | women with chest pain and coronary artery stenosis less than 50% Receives: Diagnostic Test: Mental Stress Test |
| healthy women | Sham comparator | women without chest pain and coronary artery stenosis less than 50% Receives: Diagnostic Test: Mental Stress Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: half an hour
The MBF change during mental stress test
The MBF change during mental stress test
Measured: half an hour
Secondary outcomes (7)
Blood flow reserve in women with chest pain and coronary artery stenosis < 50% .
Bood flow reserve of participants using Adenosine
Measured: half an hour
The consistency of PET-CT myocardial scanning and color Doppler echocardiography (contrast echocardiography, spot tracking) for the diagnosis of MSIMI.
The consistency between PET-CT and Doppler echocardiography (contrast echocardiography, spot tracking) in diagnosing MSIMI
Measured: 30 days
The consistency of myocardial blood flow (MBF by PET-CT) and peripheral blood flow (PAT ratio by EndoPAT) under pressure test.
The consistency between myocardial blood flow and peripheral blood flow during mental stress test
Measured: 2 hours
The neuroendocrine change in MSIMI(+) group, as compared with MSIMI(-) group.
The cause of MSIMI
Measured: 1 hour
The difference of sex hormone level between MSIMI(+) group and MSIMI(-) group
The cause of MSIMI
Measured: 1 hour
The difference of humoral immunity index level between MSIMI(+) group and MSIMI(-) group.
The cause of MSIMI
Measured: 1 hour
The difference of proteome expression level between MSIMI(+) group and MSIMI(-) group.
The cause of MSIMI
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start18 Jun 2019
- Primary completion29 Apr 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Obstructive Coronary AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qingshan Geng, Study chair, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982901
- Sponsor's protocol ID
- 2019298H(R3)
- Acronym
- MS in women
- Status last verified
- Aug 2020
- First submitted
- 2 Jun 2019
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39082421Ma 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.
PubMed 33293388
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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%
- ClinicalTrials.gov ID
- NCT03982901
- Acronym / sponsor ID
- MS in women / 2019298H(R3)
- Conditions
- Non-Obstructive Coronary Atherosclerosis
- Keywords
- Stress, Ischemia, PET-CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with chest pain | Experimental | Diagnostic Test: Mental Stress Testwomen with chest pain and coronary artery stenosis less than 50% |
| healthy women | Sham comparator | Diagnostic Test: Mental Stress Testwomen without chest pain and coronary artery stenosis less than 50% |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental Stress TestIn 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. | Diagnostic test | healthy women, women with chest pain |
Primary outcome
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
7 secondary outcomes
Blood flow reserve in women with chest pain and coronary artery stenosis < 50% .
Time frame: half an hour
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 of myocardial blood flow (MBF by PET-CT) and peripheral blood flow (PAT ratio by EndoPAT) under pressure test.
Time frame: 2 hours
The neuroendocrine change in MSIMI(+) group, as compared with MSIMI(-) group.
Time frame: 1 hour
The difference of sex hormone level between MSIMI(+) group and MSIMI(-) group
Time frame: 1 hour
The difference of humoral immunity index level between MSIMI(+) group and MSIMI(-) group.
Time frame: 1 hour
The difference of proteome expression level between MSIMI(+) group and MSIMI(-) group.
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Derived from this study: PubMed 39082421Liu 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.
- Derived from this study: PubMed 33293388Ma 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qingshan Geng study chair
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Stress Test in people with Non-Obstructive Coronary Atherosclerosis, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982901, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.