跳至主要内容
临床试验/NCT02723903
NCT02723903Unknown1 期

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

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
200
试验地点
1
主要终点
The efficacy of somatization symptom score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with suspected coronary artery disease

排除标准

  • 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.

研究组 & 干预措施

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)

干预措施: Deanxit (Drug)

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)

干预措施: Prozac (Drug)

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)

干预措施: coronary artery disease treatment (Procedure)

without CAD, with somatic symptom

Other

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

干预措施: Deanxit (Drug)

without CAD, with somatic symptom

Other

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

干预措施: Prozac (Drug)

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.

干预措施: coronary artery disease treatment (Procedure)

结局指标

主要结局

The efficacy of somatization symptom score

时间窗: 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)

次要结局

  • The efficacy of Patient Health Questionnaire(2 weeks after the first visit)
  • scale chest discomfort(2 weeks after the first visit)
  • The efficacy of Generalized Anxiety Disorder 7-items(2 weeks after the first visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验