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出境医 / 临床实验 / Clinical Features, Treatment Mode and Health Outcomes of Chest Pain Patients in China (CHANGE) (CHANGE)

Clinical Features, Treatment Mode and Health Outcomes of Chest Pain Patients in China (CHANGE) (CHANGE)

Study Description
Brief Summary:

Chinese Cardiovascular Association is an association dedicated to establishing Chest Pain Centers in hospitals that have basic qualifications and meet pre-designed quality control targets.The vision of Chinese Cardiovascular Association is the cardiovascular health of every Chinese, and the mission is to realize the early arrival of the inflection point of cardiovascular events in China.The institute of China Heart House is responsible for the daily management and implementation of Chinese Cardiovascular Association and the implementation and management of the Chest Pain Center construction project.In order to improve standard treatment and chest pain system management to achieve better outcomes for patients, China Heart House established the chest pain center database.The database includes patients in 4129 registered hospitals in 31 provinces in China who have been admitted with chest pain.The database can reflect the clinical characteristics, treatment and outcome of patients with chest pain in China.

This non-interventional, retrospective study analyzed the chest pain center database to understand the demographics, clinical characteristics, treatment patterns and clinical outcomes of patients with chest pain, and to analyze the effects of different treatment patterns, including chest pain centers and related collaborative treatment networks.The results of the study will assess the gap between the real-world situation and the recommendations of the guidelines and reflect the effect of chest pain centers and related collaborative treatment networks on the treatment process and service quality.The research results can be directly translated into the basis of medical treatment system intervention, and also provide decision-making reference for improving the certification standards and quality control of chest pain centers.


Condition or disease
Chest Pain Center STEMI - ST Elevation Myocardial Infarction

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Features, Treatment Mode and Health Outcomes of Chest Pain Patients in China: China Chest Pain Center Accreditation Programme,CHANGE-chest Pain Research
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019
Arms and Interventions
Group/Cohort
Patients with Myocardial Infarction
Outcome Measures
Primary Outcome Measures :
  1. mean and standard deviation of STEMI (ST-segment elevated Myocardial Infarction)patients [ Time Frame: baseline ]
    mean and standard deviation of STEMI patients

  2. Proportion of STEMI (ST-segment elevated Myocardial Infarction)patients [ Time Frame: baseline ]
    Proportion of female STEMI patients

  3. emergency information of STEMI patients [ Time Frame: baseline ]

    Path to hospital

    First medical contact time

    Does the patient circumvent emergency

    Telecardiogram transmission

    STEMI Reperfusion Therapy

    Initiation time of interventional surgery

    Catheter chamber activation time

    Time of arrival of patient in catheter room

    Guide wire passage time

    D2B time


  4. admission status of STEMI patients [ Time Frame: baseline ]
    admission status of STEMI patients

  5. hospitalization evaluation of STEMI patients [ Time Frame: baseline ]
    value of serum troponin and serum creatinin of STEMI patients

  6. In-hospital mortality of STEMI patients [ Time Frame: baseline ]
    In-hospital mortality of STEMI patients

  7. Hospitalization days of STEMI patients [ Time Frame: baseline ]
    Hospitalization days of STEMI patients

  8. Total cost of STEMI patients [ Time Frame: baseline ]
    Total cost of STEMI patients


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population was inpatients (18 years and older) admitted to the Chest Pain Central database with symptoms of chest pain.The database registration of this study was conducted in 4129 registered hospitals in 31 provinces in China.All hospitals participating in the Chest Pain Center program are encouraged to manage patients in accordance with local standard practices (as recommended by current Chinese guidelines).

This study will include data on all patients in the chest pain central database.

Criteria

Inclusion Criteria:

  • age 18 and above
  • patients admitted with chest pain
  • diagnosis is made by the treating physician based on local practice and clinical judgment

Exclusion Criteria:

  • No
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Huo Yong, master 13901333060 drhuoyong@163.com

Sponsors and Collaborators
China Cardiovascular Association
Peking University First Hospital
Shanghai Zhongshan Hospital
Peking University
Tracking Information
First Submitted Date July 3, 2019
First Posted Date July 10, 2019
Last Update Posted Date July 10, 2019
Estimated Study Start Date July 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2019)
  • mean and standard deviation of STEMI (ST-segment elevated Myocardial Infarction)patients [ Time Frame: baseline ]
    mean and standard deviation of STEMI patients
  • Proportion of STEMI (ST-segment elevated Myocardial Infarction)patients [ Time Frame: baseline ]
    Proportion of female STEMI patients
  • emergency information of STEMI patients [ Time Frame: baseline ]
    Path to hospital First medical contact time Does the patient circumvent emergency Telecardiogram transmission STEMI Reperfusion Therapy Initiation time of interventional surgery Catheter chamber activation time Time of arrival of patient in catheter room Guide wire passage time D2B time
  • admission status of STEMI patients [ Time Frame: baseline ]
    admission status of STEMI patients
  • hospitalization evaluation of STEMI patients [ Time Frame: baseline ]
    value of serum troponin and serum creatinin of STEMI patients
  • In-hospital mortality of STEMI patients [ Time Frame: baseline ]
    In-hospital mortality of STEMI patients
  • Hospitalization days of STEMI patients [ Time Frame: baseline ]
    Hospitalization days of STEMI patients
  • Total cost of STEMI patients [ Time Frame: baseline ]
    Total cost of STEMI patients
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Features, Treatment Mode and Health Outcomes of Chest Pain Patients in China (CHANGE)
Official Title Clinical Features, Treatment Mode and Health Outcomes of Chest Pain Patients in China: China Chest Pain Center Accreditation Programme,CHANGE-chest Pain Research
Brief Summary

Chinese Cardiovascular Association is an association dedicated to establishing Chest Pain Centers in hospitals that have basic qualifications and meet pre-designed quality control targets.The vision of Chinese Cardiovascular Association is the cardiovascular health of every Chinese, and the mission is to realize the early arrival of the inflection point of cardiovascular events in China.The institute of China Heart House is responsible for the daily management and implementation of Chinese Cardiovascular Association and the implementation and management of the Chest Pain Center construction project.In order to improve standard treatment and chest pain system management to achieve better outcomes for patients, China Heart House established the chest pain center database.The database includes patients in 4129 registered hospitals in 31 provinces in China who have been admitted with chest pain.The database can reflect the clinical characteristics, treatment and outcome of patients with chest pain in China.

This non-interventional, retrospective study analyzed the chest pain center database to understand the demographics, clinical characteristics, treatment patterns and clinical outcomes of patients with chest pain, and to analyze the effects of different treatment patterns, including chest pain centers and related collaborative treatment networks.The results of the study will assess the gap between the real-world situation and the recommendations of the guidelines and reflect the effect of chest pain centers and related collaborative treatment networks on the treatment process and service quality.The research results can be directly translated into the basis of medical treatment system intervention, and also provide decision-making reference for improving the certification standards and quality control of chest pain centers.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

The study population was inpatients (18 years and older) admitted to the Chest Pain Central database with symptoms of chest pain.The database registration of this study was conducted in 4129 registered hospitals in 31 provinces in China.All hospitals participating in the Chest Pain Center program are encouraged to manage patients in accordance with local standard practices (as recommended by current Chinese guidelines).

This study will include data on all patients in the chest pain central database.

Condition
  • Chest Pain Center
  • STEMI - ST Elevation Myocardial Infarction
Intervention Not Provided
Study Groups/Cohorts Patients with Myocardial Infarction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 9, 2019)
50000
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age 18 and above
  • patients admitted with chest pain
  • diagnosis is made by the treating physician based on local practice and clinical judgment

Exclusion Criteria:

  • No
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Huo Yong, master 13901333060 drhuoyong@163.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04014972
Other Study ID Numbers GUSU19005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party China Cardiovascular Association
Study Sponsor China Cardiovascular Association
Collaborators
  • Peking University First Hospital
  • Shanghai Zhongshan Hospital
  • Peking University
Investigators Not Provided
PRS Account China Cardiovascular Association
Verification Date July 2019