NCT02723903

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

5 years

First QC Date

February 15, 2016

Last Update Submit

March 2, 2020

Conditions

Syndrome X

Keywords

somatization symptom scoreSSS checklistcoronary angiographyPatient Health QuestionnaireGeneralized Anxiety Disorder 7-items

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • scale chest discomfort

    2 weeks after the first visit

  • The efficacy of Patient Health Questionnaire

    2 weeks after the first visit

  • The efficacy of Generalized Anxiety Disorder 7-items

    2 weeks after the first visit

Study Arms (4)

with CAD and somatic symptom

OTHER

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: DeanxitDrug: ProzacProcedure: coronary artery disease treatment

without CAD, with somatic symptom

OTHER

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

Drug: DeanxitDrug: Prozac

without CAD, without somatic symptom

NO INTERVENTION

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

with CAD, without somatic symptom

OTHER

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

Interventions

DeanxitDRUG

we use Deanxit for the patient with anxiety

Also known as: Deanxit as anti-anxiety treatment
with CAD and somatic symptomwithout CAD, with somatic symptom
ProzacDRUG

we use Prozac for the patient with depression

Also known as: Prozac as anti-depression treatment
with CAD and somatic symptomwithout CAD, with somatic symptom
coronary artery disease treatmentPROCEDURE

including medication, coronary artery stent implantation according to the severity of stenosis of the coronary arteries

Also known as: re-vascularization
with CAD and somatic symptomwith CAD, without somatic symptom

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with suspected coronary artery disease

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Microvascular Angina

Interventions

flupentixol, melitracen drug combinationFluoxetine

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Mao Jialiang, Docter

    Renji hosipital,Jiaotong University, School of Medicine

    STUDY CHAIR

Central Study Contacts

Mao Jialiang, Docter

CONTACT

13311606283maoji@aliyun.com

Jiang Meng, Doctor

CONTACT

13788912766jiangmeng0919@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2016

First Posted

March 31, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)