Hierarchical Treatment Based on Somatization Symptom Checklist

Syndrome X Clinical Trial

Official title:

Efficacy of Hierarchical Treatment For Suspected Coronary Heart Disease Based on Somatization Symptom Checklist and Coronary Angiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02723903
• Other study ID #: 81470391
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 2015
• Est. completion date: December 2021

Study information

• Verified date: March 2020
• Source: RenJi Hospital
• Contact: Mao Jialiang, Docter
• Phone: 13311606283
• Email: maoji[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A comparative study is conducted on the patients with suspected coronary artery disease (CAD). The patient will undergo coronary angiography after a somatic symptom scale (SSS) survey is carried out combining with Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder 7-items (GAD-7). Patient is then treated according to the checklist score and coronary angiography result. The efficacy, sensitivity and specificity of the SSS checklist will be evaluated during following up.

Description:

The presentation of physical complaints such as chest discomfort suggestive of suspicious coronary artery disease (CAD) but remain unexplained after negative finding from coronary angiography represents one of the most frustrating and puzzling problems in clinical medicine.A comparative study is conducted on the patients with suspected coronary artery disease. A somatic symptom scale (SSS) survey is carried out combining with Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder 7-items (GAD-7). Patient is treated according to the checklist score and coronary angiography result. Three surveys will be re-conducted 2 weeks after treatment. The sensitivity and specificity of the SSS checklist will be evaluated during following up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with suspected coronary artery disease

Exclusion Criteria:

• patients who have lost their self assessments of capacity.

• patients who have been previously confirmed serious mental disorders.

• patients who is taking anti-anxiety agents or anti-depression agents.

Related Conditions & MeSH terms

• Syndrome X

Intervention

Drug:
• Deanxit
we use Deanxit for the patient with anxiety
• Prozac
we use Prozac for the patient with depression

Procedure:
• coronary artery disease treatment
including medication, coronary artery stent implantation according to the severity of stenosis of the coronary arteries

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of somatization symptom score	observe the efficacy by the score of somatic symptom scale (SSS), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7-items (GAD-7)	2 weeks after the first visit
Secondary	scale chest discomfort	observe if the chest discomfort no change, alleviate or disappear	2 weeks after the first visit
Secondary	The efficacy of Patient Health Questionnaire	observe the efficacy by the score of Patient Health Questionnaire (PHQ-9)	2 weeks after the first visit
Secondary	The efficacy of Generalized Anxiety Disorder 7-items	observe the efficacy by the score of Generalized Anxiety Disorder 7-items (GAD-7)	2 weeks after the first visit