Effect of Mental Stress on Myocardial Perfusion in Women

NCT03982901 | Completed DMC

• 1 other identifier: 2019298H(R3)
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Obstructive Coronary Atherosclerosis

Keywords

Stress; Ischemia; PET-CT

Outcome Measures

Primary Outcomes (2)

• 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.

  half an hour

• The MBF change during mental stress test

  The MBF change during mental stress test

  half an hour

Secondary Outcomes (7)

• Blood flow reserve in women with chest pain and coronary artery stenosis < 50% .

  half an hour

• The consistency of PET-CT myocardial scanning and color Doppler echocardiography (contrast echocardiography, spot tracking) for the diagnosis of MSIMI.

  30 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 sex hormone level between MSIMI(+) group and MSIMI(-) group

  1 hour

Study Arms (2)

women with chest pain

EXPERIMENTAL

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

Diagnostic Test: Mental Stress Test

healthy women

SHAM COMPARATOR

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

Diagnostic Test: Mental Stress Test

Interventions

Mental Stress Test 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 with chest pain

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Related Publications (2)

• 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.

  PMID: 39082421 DERIVED

• 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.

  PMID: 33293388 DERIVED

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qingshan Geng

  Guangdong Provincial People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: June 12, 2019
• Study Start: June 18, 2019
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: December 9, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)