Clinical trial NCT04664387: Somatic Symptom Disorders in Patients With Myocardial Bridge
Official title: EARLY Assessment of Somatic Symptom Disorder in Patients With MYOcardial Bridge by Somatic Symptom Scale China (SSS-CN) (EARLY-MYO-SSS-CN-Ⅱ)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Bridge
Somatic Symptom Disorder
Keywords: myocardial bridge
somatic symptom disorder
SSS-CN
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 1357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive suspected CAD inpatients from Renji cardiology department.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the score of Somatic Symptom Scale-China (SSS-CN)
timeFrame: within 24 hours before the coronary angiography.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
affiliation: RenJi Hospital
name: Meng Jiang, MD
role: STUDY_CHAIR
References: