Myocardial BridgeNCT04664387
Somatic Symptom Disorders in Patients With Myocardial Bridge
An observational study of Myocardial Bridge and Somatic Symptom Disorder, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Bridge, Somatic Symptom Disorder
- What is being tested?
- coronary angiography
- How many people
- 1,357 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2016to 8 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive suspected CAD inpatients from Renji cardiology department.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Myocardial Bridge, Somatic Symptom Disorder
- Being tested
- coronary angiography
- Keywords
- myocardial bridge, somatic symptom disorder, SSS-CN
- Medical subject headings
- Myocardial Bridging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary angiographyDiagnostic test
A coronary angiography is a test to find out if there is stenosis in coronary artery.
| Study group | Role | What they receive |
|---|---|---|
| patients with myocardial bridge | patients who underwent coronary angiography and was diagnosed as myocardial bridge Receives: Diagnostic Test: coronary angiography | |
| patients without myocardial bridge | patients who underwent coronary angiography and was diagnosed as without myocardial bridge Receives: Diagnostic Test: coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 24 hours before the coronary angiography.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start30 Oct 2016
- Primary completion8 May 2020
- Study completion8 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial BridgeStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,357 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng Jiang, MD, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664387
- Sponsor's protocol ID
- SSSCN202010
- Status last verified
- Oct 2020
- First submitted
- 6 Dec 2020
- Last updated
- 17 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04664387
- Acronym / sponsor ID
- SSSCN202010
- Conditions
- Myocardial Bridge, Somatic Symptom Disorder
- Keywords
- myocardial bridge, somatic symptom disorder, SSS-CN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,357 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 30 Oct 2016 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with myocardial bridge | – | Diagnostic Test: coronary angiographypatients who underwent coronary angiography and was diagnosed as myocardial bridge |
| patients without myocardial bridge | – | Diagnostic Test: coronary angiographypatients who underwent coronary angiography and was diagnosed as without myocardial bridge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive suspected CAD inpatients from Renji cardiology department.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary angiographyA coronary angiography is a test to find out if there is stenosis in coronary artery. | Diagnostic test | patients with myocardial bridge, patients without myocardial bridge |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng Jiang, MD study chair
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Bridge and Somatic Symptom Disorder, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the score of Somatic Symptom Scale-China (SSS-CN) (time frame: within 24 hours before the coronary angiography.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.