NCT04664387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,357

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
Last Updated

November 17, 2022

Status Verified

October 1, 2020

Enrollment Period

3.5 years

First QC Date

December 6, 2020

Last Update Submit

November 14, 2022

Conditions

Keywords

myocardial bridgesomatic symptom disorderSSS-CN

Outcome Measures

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.

    within 24 hours before the coronary angiography.

Study Arms (2)

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

coronary angiographyDIAGNOSTIC_TEST

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

patients with myocardial bridgepatients without myocardial bridge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive suspected CAD inpatients from Renji cardiology department.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Myocardial Bridging

Interventions

Coronary Angiography

Condition Hierarchy (Ancestors)

Coronary Vessel AnomaliesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyRadiographyDiagnostic Techniques, CardiovascularHeart Function Tests

Study Officials

  • Meng Jiang, MD

    RenJi Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2020

First Posted

December 11, 2020

Study Start

October 30, 2016

Primary Completion

May 8, 2020

Study Completion

May 8, 2020

Last Updated

November 17, 2022

Record last verified: 2020-10

Locations