Hierarchical Treatment Based on Somatization Symptom Checklist

March 2, 2020 updated by: RenJi Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mao Jialiang, Docter
  • Phone Number: 68383477 13311606283
  • Email: maoji@aliyun.com

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Renji Hospital
        • Contact:
          • Wang lingling, Postgraduate
          • Phone Number: 15000053961
        • Contact:
          • Chen bingxu, Postgraduate
          • Phone Number: 15800539513

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of somatization symptom score
Time Frame: 2 weeks after the first visit
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
Time Frame: 2 weeks after the first visit
observe if the chest discomfort no change, alleviate or disappear
2 weeks after the first visit
The efficacy of Patient Health Questionnaire
Time Frame: 2 weeks after the first visit
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
Time Frame: 2 weeks after the first visit
observe the efficacy by the score of Generalized Anxiety Disorder 7-items (GAD-7)
2 weeks after the first visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Study Chair: Mao Jialiang, Docter, Renji hosipital,Jiaotong University, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 15, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81470391

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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