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NCT Number: NCT04664387

Somatic Symptom Disorders in Patients With Myocardial Bridge

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Coronary angiography

Diagnostic Test

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

Primary outcomes

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

    Time frame: within 24 hours before the coronary angiography.

    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.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

EARLY Assessment of Somatic Symptom Disorder in Patients With MYOcardial Bridge by Somatic Symptom Scale China (SSS-CN) (EARLY-MYO-SSS-CN-Ⅱ)

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2020
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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