Hierarchical Treatment Based on Somatization Symptom Checklist

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Syndrome X

Intervention / Treatment
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* Drug: Deanxit
* Drug: Prozac
* Procedure: coronary artery disease treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: with CAD and somatic symptom<br>Patients with the coronary artery disease and with the somatization symptom, the investigators treat the patients according to the guideline for coronary artery disease and anti-somatic agents (Deanxit, Prozac according to the somatization type) | Drug: Deanxit<br>* we use Deanxit for the patient with anxiety<br>* Other names: Deanxit as anti-anxiety treatment;Drug: Prozac<br>* we use Prozac for the patient with depression<br>* Other names: Prozac as anti-depression treatment;Procedure: coronary artery disease treatment<br>* including medication, coronary artery stent implantation according to the severity of stenosis of the coronary arteries<br>* Other names: re-vascularization;|
| Other: without CAD, with somatic symptom<br>Only somatic symptom is presented, anti-somatic agents is prescribed (Deanxit, Prozac according to the somatization type) | Drug: Deanxit<br>* we use Deanxit for the patient with anxiety<br>* Other names: Deanxit as anti-anxiety treatment;Drug: Prozac<br>* we use Prozac for the patient with depression<br>* Other names: Prozac as anti-depression treatment;|
| No Intervention: without CAD, without somatic symptom<br>Have neither coronary artery disease nor somatic symptom, continue follow-up. | |
| Other: with CAD, without somatic symptom<br>Patient with the coronary artery disease, without the somatization symptom, the investigators treat the patients according to coronary artery disease treatment guideline including coronary artery stent implantation,medication according to the severity of stenosis of the coronary arteries. | Procedure: coronary artery disease treatment<br>* including medication, coronary artery stent implantation according to the severity of stenosis of the coronary arteries<br>* Other names: re-vascularization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scale chest discomfort | observe if the chest discomfort no change, alleviate or disappear | 2 weeks after the first visit | 
| The efficacy of Patient Health Questionnaire | observe the efficacy by the score of Patient Health Questionnaire (PHQ-9) | 2 weeks after the first visit | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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somatization symptom score, SSS checklist, coronary angiography, Patient Health Questionnaire, Generalized Anxiety Disorder 7-items