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Hierarchical Treatment Based on Somatization Symptom Checklist

Primary Purpose

Syndrome X

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Deanxit
Prozac
coronary artery disease treatment
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Syndrome X focused on measuring somatization symptom score, SSS checklist, coronary angiography, Patient Health Questionnaire, Generalized Anxiety Disorder 7-items

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Renji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

No Intervention

Other

Arm Label

with CAD and somatic symptom

without CAD, with somatic symptom

without CAD, without somatic symptom

with CAD, without somatic symptom

Arm Description

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)

Only somatic symptom is presented, anti-somatic agents is prescribed (Deanxit, Prozac according to the somatization type)

Have neither coronary artery disease nor somatic symptom, continue follow-up.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

scale chest discomfort
observe if the chest discomfort no change, alleviate or disappear
The efficacy of Patient Health Questionnaire
observe the efficacy by the score of Patient Health Questionnaire (PHQ-9)
The efficacy of Generalized Anxiety Disorder 7-items
observe the efficacy by the score of Generalized Anxiety Disorder 7-items (GAD-7)

Full Information

First Posted
February 15, 2016
Last Updated
March 2, 2020
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02723903
Brief Title
Hierarchical Treatment Based on Somatization Symptom Checklist
Official Title
Efficacy of Hierarchical Treatment For Suspected Coronary Heart Disease Based on Somatization Symptom Checklist and Coronary Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syndrome X
Keywords
somatization symptom score, SSS checklist, coronary angiography, Patient Health Questionnaire, Generalized Anxiety Disorder 7-items

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
with CAD and somatic symptom
Arm Type
Other
Arm Description
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)
Arm Title
without CAD, with somatic symptom
Arm Type
Other
Arm Description
Only somatic symptom is presented, anti-somatic agents is prescribed (Deanxit, Prozac according to the somatization type)
Arm Title
without CAD, without somatic symptom
Arm Type
No Intervention
Arm Description
Have neither coronary artery disease nor somatic symptom, continue follow-up.
Arm Title
with CAD, without somatic symptom
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Deanxit
Other Intervention Name(s)
Deanxit as anti-anxiety treatment
Intervention Description
we use Deanxit for the patient with anxiety
Intervention Type
Drug
Intervention Name(s)
Prozac
Other Intervention Name(s)
Prozac as anti-depression treatment
Intervention Description
we use Prozac for the patient with depression
Intervention Type
Procedure
Intervention Name(s)
coronary artery disease treatment
Other Intervention Name(s)
re-vascularization
Intervention Description
including medication, coronary artery stent implantation according to the severity of stenosis of the coronary arteries
Primary Outcome Measure Information:
Title
The efficacy of somatization symptom score
Description
observe the efficacy by the score of somatic symptom scale (SSS), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7-items (GAD-7)
Time Frame
2 weeks after the first visit
Secondary Outcome Measure Information:
Title
scale chest discomfort
Description
observe if the chest discomfort no change, alleviate or disappear
Time Frame
2 weeks after the first visit
Title
The efficacy of Patient Health Questionnaire
Description
observe the efficacy by the score of Patient Health Questionnaire (PHQ-9)
Time Frame
2 weeks after the first visit
Title
The efficacy of Generalized Anxiety Disorder 7-items
Description
observe the efficacy by the score of Generalized Anxiety Disorder 7-items (GAD-7)
Time Frame
2 weeks after the first visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mao Jialiang, Docter
Phone
13311606283
Ext
68383477
Email
maoji@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Meng, Doctor
Phone
13788912766
Ext
58752445
Email
jiangmeng0919@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mao Jialiang, Docter
Organizational Affiliation
Renji hosipital,Jiaotong University, School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang lingling, Postgraduate
Phone
15000053961
First Name & Middle Initial & Last Name & Degree
Chen bingxu, Postgraduate
Phone
15800539513

12. IPD Sharing Statement

Plan to Share IPD
No

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Hierarchical Treatment Based on Somatization Symptom Checklist

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