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CompletedNCT04664387Updated Nov 17, 2022

Somatic Symptom Disorders in Patients With Myocardial Bridge

An observational study in Myocardial Bridge and Somatic Symptom Disorder, sponsored by RenJi Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-17.

Sponsored by RenJi Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
1,357
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study was to investigate the prevalence of physical and mental disorder in the population of patients with myocardial bridge and to describe the relationship between clinical features and the occurrence of somatic disorder.

Read the detailed description

Myocardial bridge (MB), a congenital cardiac anomaly, is an unignored contribution to chest pain. Patients with MB often complain about chest discomfort more serious than the degree of vessel compression. The symptoms are also often inconsistence with the degree of coronary stenosis. Reports suggested that patients with MB may companioned with depression and anxiety. Moreover, patients with MB often have other systemic complaints including stomach pain, pain on the back, ear blockage, et al. Investigators assume that somatic symptom disorder (SSD) may play a part in aggregating the severity of symptoms. In order to screen SSD, investigators previously developed the Somatic Symptom Scale-China (SSS-CN) questionnaire. It is a somatic and psychological symptom scale which was developed based on the DSM-5 to assess a combination of psychological, behavioral and somatic symptoms. It is designed to assess the presence and severity of the symptoms. Investigators have validated its reliability and validity in a previous study. The purpose of this study was to investigate the prevalence of physical and mental disorder in the population of patients with MB and to describe the relationship between clinical features and the occurrence of somatic disorder.

02

Conditions studied

  • Myocardial Bridge
  • Somatic Symptom Disorder

Keywords

  • myocardial bridge
  • somatic symptom disorder
  • SSS-CN
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consecutive suspected CAD inpatients from Renji cardiology department.

Inclusion criteria

  • cardiology inpatients with the age older than 18, complained with chest discomfort and was suspected with coronary artery disease.
  • undertook Somatic Symptom Scale-China (SSS-CN) questionnaire, Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) questionnaires.
  • underwent cardiac angiography.
  • agree to participate.

Exclusion criteria

Exclusion Criteria:

  • patients who are in emergency or unconsciousness.
  • patients who refuse to participate or with unfinished questionnaire.
  • the questionnaires were undertook after the angiography.
  • patients who have previously been confirmed to have mental disorders, mental retardation or dementia, cannot finish questionnaires
  • patients who currently take anti-anxiety or anti-depression agents.
  • patients who have been confirmed to have heart diseases other than coronary vascular disease.
  • patients who have been previously confirmed to have other physical diseases.
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
1,357 participants (actual)
Patient registry
No

Groups and cohorts

  • patients with myocardial bridge

    patients who underwent coronary angiography and was diagnosed as myocardial bridge

    Diagnostic Test: coronary angiography

  • patients without myocardial bridge

    patients who underwent coronary angiography and was diagnosed as without myocardial bridge

    Diagnostic Test: coronary angiography

Interventions

  • Diagnostic testcoronary angiography

    A coronary angiography is a test to find out if there is stenosis in coronary artery.

05

What researchers measure

Primary outcomes

  1. the score of Somatic Symptom Scale-China (SSS-CN)

    to compare the score of Somatic Symptom Scale-China questionnaire between patients with and without myocardial bridge. SSS-CN is a self-administered questionnaire with 20 items and scoring 1, 2, 3, 4 to each item. The total score is from 20 to 80. The higher the score is, the higher frequency that the symptoms presented.

    Time frame: within 24 hours before the coronary angiography.

06

Study locations

1 site
  • Renji Hospital
    Shanghai, 200127, China
07

Registry details

Key details

Study ID
NCT04664387
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Dec 11, 2020
Start date
Oct 30, 2016
Primary completion
May 8, 2020
Completion
May 8, 2020
Last update
Nov 17, 2022

Study contacts

Meng Jiang, MD
study chair · RenJi Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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