Somatic Symptom Disorders in Patients With Myocardial Bridge

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

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.

Study Overview

• Status: Completed
• Conditions: Somatic Symptom Disorder; Myocardial Bridge
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1357

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200127
    • RenJi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive suspected CAD inpatients from Renji cardiology department.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 24 hours before the coronary angiography.

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Chair: Meng Jiang, MD, RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2016
• Primary Completion (Actual): May 8, 2020
• Study Completion (Actual): May 8, 2020

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: SSS-CN; somatic symptom disorder; myocardial bridge
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Coronary Vessel Anomalies; Disease; Medically Unexplained Symptoms; Myocardial Bridging
• Other Study ID Numbers: SSSCN202010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No