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出境医 / 临床实验 / reGional Network for Acute Myocardial Infarction (GAMI)

reGional Network for Acute Myocardial Infarction (GAMI)

Study Description
Brief Summary:
Incidence of ST-segment Elevation Myocardial Infarction(STEMI) is rising and the existing emergency medical aid system for STEMI was not enough for timely perfusion treatment. No existing research with high-quality data focuses on the characteristic of STEMI incidence and regional network construction. Aiming of Guangdong GAMI(reGional network for Acute Myocardial Infarction) project is to establish effective collaborative regional network system for STEMI patients treatment.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Acute Myocardial Infarction STEMI - ST Elevation Myocardial Infarction Behavioral: public education and network construction Not Applicable

Detailed Description:
The project of Guangdong GAMI(reGional network for Acute Myocardial Infarction) is being conducted during 2015-2019 in four districts with diverse economic development across Guangdong province. All the ST-segment elevation myocardial infarction (STEMI) patients admitted in the hospital within 30 days from the symptom onset were enrolled and the designed sample size was 4000 patients. The key data of the timeline of STEMI onset and treatment were precisely recorded. Other details of STEMI treatment in hospitals such as laboratory data and medication were also collected. During the research period, actions of both optimizing the regional STEMI patients transfer and treatment to shorten the medical delay, as well as educating the public to improve their awareness of early treatment of STEMI were taken meanwhile. Timeline of STEMI patients visit and treatment were compared before and after every half year to elevate the effect of the actions and optimize the following action to better shorten the treatment delay. In addition, laboratory data, medication, and follow-up information were recorded in a database for further analysis regarding the STEMI patient treatment.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Construction of Modern reGional Network for Acute Myocardial Infarction
Actual Study Start Date : June 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: public education and network construction

Public education was conducted to evaluate the effectiveness on patients delay of ST-Segment Elevation Myocardial Infarction treatment.

Network construction was conducted to evaluate the effectiveness to minimize the medical delay of ST-Segment Elevation Myocardial Infarction treatment.

 Behavioral: public education and network construction
Publication education includes multiple methods of acute myocardial infarction knowledge education. Network construction includes regional connection of ST-Segment Elevation Myocardial Infarction patients transfer for percutaneous coronary intervention treatment, as well as physicians skill improvement in primary hospital.
Outcome Measures
Primary Outcome Measures :
  1. change of annual average reperfusion time of ST-Segment Elevation Myocardial Infarction patients [ Time Frame: 4 years ]
    annual average reperfusion time of ST-Segment Elevation Myocardial Infarction was analyzed, after public education and network construction, decrease of annual average reperfusion time of STEMI patients were analyzed to testified the effectiveness of the intervention.


Secondary Outcome Measures :
  1. public awareness of Acute Myocardial Infarction [ Time Frame: 4 years ]
    public awareness of Acute Myocardial Infarction was analyzed by sampling questionnaire survey in each year to conclude the change after the public education intervention

  2. change of in-hospital mortality of ST-Segment Elevation Myocardial Infarction [ Time Frame: during hospitalization (an average of 2 weeks) ]
    ST-Segment Elevation Myocardial Infarction patients in-hospital mortality were collected in each year to conclude the in-hospital mortality rate change

  3. change of 30-days mortality of ST-Segment Elevation Myocardial Infarction [ Time Frame: 30 days ]
    ST-Segment Elevation Myocardial Infarction patients 30-days mortality were followed up in each year to conclude the mortality rate change

  4. change of 1-year mortality of ST-Segment Elevation Myocardial Infarction [ Time Frame: 1 year ]
    ST-Segment Elevation Myocardial Infarction patients 1-year mortality were followed up in each year to conclude the mortality rate change


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ST-Segment Elevation Myocardial Infarction patients within 30 days since symptoms onset

Exclusion Criteria:

  • None
Contacts and Locations

Contacts
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Contact: Jiyan Chen, Doctor chenjiyandr@126.com
Contact: Yong Liu, Doctor liuyong2099@126.com

Locations
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China, Guangdong
Dongguan People's Hospital Recruiting
Dongguan, Guangdong, China, 523000
Contact: Jianfeng Ye         
Contact: Shaohui Su         
The First People's Hospital of Shunde Foshan Recruiting
Foshan, Guangdong, China, 528000
Contact: Yunzhao Hu         
Contact: Wensheng Li         
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 501080
Contact: Yong Liu, MD    86-20-83827812 ext 10528    liuyong2099@126.com   
Guangzhou Panyu Central Hospital Recruiting
Guangzhou, Guangdong, China, 511400
Contact: Wenzhu Zhang         
Contact: Mingcai Song         
Maoming People's Hospital Recruiting
Maoming, Guangdong, China, 525000
Contact: Yan Liang         
Contact: Cong Chen         
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Maoming People's Hospital
Dongguan People's Hospital
First People's Hospital, Shunde China
Guangzhou Panyu Central Hospital
Investigators
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Principal Investigator: Yan Liang Maoming People's Hospital
Principal Investigator: Jianfeng Ye Dongguan People's Hospital
Principal Investigator: Yunzhao Hu The first People's Hospital of Shunde, Foshan
Principal Investigator: Wenzhu Zhang Guangzhou Panyu Central Hospital
Tracking Information
First Submitted Date  ICMJE April 21, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE June 2015
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019) 		change of annual average reperfusion time of ST-Segment Elevation Myocardial Infarction patients [ Time Frame: 4 years ]
annual average reperfusion time of ST-Segment Elevation Myocardial Infarction was analyzed, after public education and network construction, decrease of annual average reperfusion time of STEMI patients were analyzed to testified the effectiveness of the intervention.
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		decrease of annual average reperfusion time of ST-Segment Elevation Myocardial Infarction patients [ Time Frame: 4 years ]
annual average reperfusion time of ST-Segment Elevation Myocardial Infarction was analyzed, after public education and network construction, decrease of annual average reperfusion time of STEMI patients were analyzed to testified the effectiveness of the intervention.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • public awareness of Acute Myocardial Infarction [ Time Frame: 4 years ]
    public awareness of Acute Myocardial Infarction was analyzed by sampling questionnaire survey in each year to conclude the change after the public education intervention
  • change of in-hospital mortality of ST-Segment Elevation Myocardial Infarction [ Time Frame: during hospitalization (an average of 2 weeks) ]
    ST-Segment Elevation Myocardial Infarction patients in-hospital mortality were collected in each year to conclude the in-hospital mortality rate change
  • change of 30-days mortality of ST-Segment Elevation Myocardial Infarction [ Time Frame: 30 days ]
    ST-Segment Elevation Myocardial Infarction patients 30-days mortality were followed up in each year to conclude the mortality rate change
  • change of 1-year mortality of ST-Segment Elevation Myocardial Infarction [ Time Frame: 1 year ]
    ST-Segment Elevation Myocardial Infarction patients 1-year mortality were followed up in each year to conclude the mortality rate change
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • public awareness of Acute Myocardial Infarction [ Time Frame: 4 years ]
    public awareness of Acute Myocardial Infarction was analyzed by sampling questionnaire survey in each year to conclude the change after the public education intervention
  • decrease of in-hospital mortality of ST-Segment Elevation Myocardial Infarction [ Time Frame: during hospitalization (an average of 2 weeks) ]
    ST-Segment Elevation Myocardial Infarction patients in-hospital mortality were collected in each year to conclude the in-hospital mortality rate change
  • decrease of 30-days mortality of ST-Segment Elevation Myocardial Infarction [ Time Frame: 30 days ]
    ST-Segment Elevation Myocardial Infarction patients 30-days mortality were followed up in each year to conclude the mortality rate change
  • decrease of 1-year mortality of ST-Segment Elevation Myocardial Infarction [ Time Frame: 1 year ]
    ST-Segment Elevation Myocardial Infarction patients 1-year mortality were followed up in each year to conclude the mortality rate change
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE reGional Network for Acute Myocardial Infarction
Official Title  ICMJE Construction of Modern reGional Network for Acute Myocardial Infarction
Brief Summary Incidence of ST-segment Elevation Myocardial Infarction(STEMI) is rising and the existing emergency medical aid system for STEMI was not enough for timely perfusion treatment. No existing research with high-quality data focuses on the characteristic of STEMI incidence and regional network construction. Aiming of Guangdong GAMI(reGional network for Acute Myocardial Infarction) project is to establish effective collaborative regional network system for STEMI patients treatment.
Detailed Description The project of Guangdong GAMI(reGional network for Acute Myocardial Infarction) is being conducted during 2015-2019 in four districts with diverse economic development across Guangdong province. All the ST-segment elevation myocardial infarction (STEMI) patients admitted in the hospital within 30 days from the symptom onset were enrolled and the designed sample size was 4000 patients. The key data of the timeline of STEMI onset and treatment were precisely recorded. Other details of STEMI treatment in hospitals such as laboratory data and medication were also collected. During the research period, actions of both optimizing the regional STEMI patients transfer and treatment to shorten the medical delay, as well as educating the public to improve their awareness of early treatment of STEMI were taken meanwhile. Timeline of STEMI patients visit and treatment were compared before and after every half year to elevate the effect of the actions and optimize the following action to better shorten the treatment delay. In addition, laboratory data, medication, and follow-up information were recorded in a database for further analysis regarding the STEMI patient treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Coronary Heart Disease
  • Acute Myocardial Infarction
  • STEMI - ST Elevation Myocardial Infarction
Intervention  ICMJE Behavioral: public education and network construction
Publication education includes multiple methods of acute myocardial infarction knowledge education. Network construction includes regional connection of ST-Segment Elevation Myocardial Infarction patients transfer for percutaneous coronary intervention treatment, as well as physicians skill improvement in primary hospital.
Study Arms  ICMJE Experimental: public education and network construction

Public education was conducted to evaluate the effectiveness on patients delay of ST-Segment Elevation Myocardial Infarction treatment.

Network construction was conducted to evaluate the effectiveness to minimize the medical delay of ST-Segment Elevation Myocardial Infarction treatment.

Intervention: Behavioral: public education and network construction
Publications * Lu J, Xuan S, Downing NS, Wu C, Li L, Krumholz HM, Jiang L. Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Million Persons Project pilot. BMJ Open. 2016 Jan 4;6(1):e010200. doi: 10.1136/bmjopen-2015-010200. Erratum in: BMJ Open. 2016 Jun 10;6(6):e010200corr1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019) 		4000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ST-Segment Elevation Myocardial Infarction patients within 30 days since symptoms onset

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03928119
Other Study ID Numbers  ICMJE 2014B070706010
Has Data Monitoring Committee Yes
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  ICMJE
Plan to Share IPD: No
Responsible Party Jiyan Chen, Guangdong Provincial People's Hospital
Study Sponsor  ICMJE Guangdong Provincial People's Hospital
Collaborators  ICMJE
  • Maoming People's Hospital
  • Dongguan People's Hospital
  • First People's Hospital, Shunde China
  • Guangzhou Panyu Central Hospital
Investigators  ICMJE
Principal Investigator: Yan Liang Maoming People's Hospital
Principal Investigator: Jianfeng Ye Dongguan People's Hospital
Principal Investigator: Yunzhao Hu The first People's Hospital of Shunde, Foshan
Principal Investigator: Wenzhu Zhang Guangzhou Panyu Central Hospital
PRS Account Guangdong Provincial People's Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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