Somatic Symptom Disorders in Patients With Myocardial Bridge (EARLY-MYO-SSS-CN)

Sponsor

RenJi Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04664387

Collaborator

(none)

1,394

Enrollment

Location

42.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Bridge Somatic Symptom Disorder	Diagnostic Test: coronary angiography

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.

Study Design

Study Type:

Observational

Actual Enrollment :

1394 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 30, 2016

Actual Primary Completion Date :

May 8, 2020

Actual Study Completion Date :

May 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
patients with myocardial bridge patients who underwent coronary angiography and was diagnosed as myocardial bridge	Diagnostic Test: coronary angiography A coronary angiography is a test to find out if there is stenosis in coronary artery.
patients without myocardial bridge patients who underwent coronary angiography and was diagnosed as without myocardial bridge	Diagnostic Test: coronary angiography A coronary angiography is a test to find out if there is stenosis in coronary artery.

Arm

Intervention/Treatment

patients with myocardial bridge

patients who underwent coronary angiography and was diagnosed as myocardial bridge

Diagnostic Test: coronary angiography

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

patients without myocardial bridge

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

Diagnostic Test: coronary angiography

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.