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reGional Network for Acute Myocardial Infarction (GAMI)

Primary Purpose

Coronary Heart Disease, Acute Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
public education and network construction
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Heart Disease focused on measuring Acute myocardial infarction, STEMI, regional network

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All adult patients who suspected diagnosis with STEMI.

Exclusion Criteria:

  1. patients refused to undergo coronary angiography;
  2. patients were confirmed as non-STEMI by coronary angiography or the course of STEMI over 1 month;
  3. patients occurred onset STEMI during hospitalization in hospitals

Sites / Locations

  • Longyan First Hospital Affiliated to Fujian Medical University
  • Dongguan People's Hospital
  • Shunde Hospital of Southern Medical University
  • Guangdong Provincial People's Hospital
  • Guangzhou Panyu Central Hospital
  • Maoming People's Hospital
  • Shenzhen People's Hospital
  • People's Hospital of Yangjiang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

community public education, non-PCI center and emergency transfer system improvement, and inhospital green-channal optimization for PCI center.

Usual care of AMI public and medical health service

Outcomes

Primary Outcome Measures

Receipt of reperfusion therapy within 12 hoursInfarction patients
The primary outcome was the proportion of patients who received symptom-to-reperfusion treatment within 12 hours.

Secondary Outcome Measures

Onset-to-admission time within 12 hours
The proportion of patients who take a symptom-to-admission period within 12 hours.
Door-to-balloon time within 90 minutes
The proportion of patients who take a door-to-balloon period within 90 minutes.
In-hospital clinical outcomes
The incidence of several in-hospital outcomes (in-hospital death; and major adverse cardiac events [MACEs], which mainly included in-hospital death, recurrence of myocardial infarction, and stroke); the length of stay.
1-year all-cause mortality
Total mortality between 30 days and 1 year after discharge.

Full Information

First Posted
April 21, 2019
Last Updated
May 26, 2022
Sponsor
Guangdong Provincial People's Hospital
Collaborators
Maoming People's Hospital, Dongguan People's Hospital, Southern Medical University, China, Guangzhou Panyu Central Hospital, People's Hospital of Yangjiang, Shenzhen People's Hospital, Longyan First Hospital, Affiliated to Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03928119
Brief Title
reGional Network for Acute Myocardial Infarction
Acronym
GAMI
Official Title
Construction of Modern reGional Network for Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
Collaborators
Maoming People's Hospital, Dongguan People's Hospital, Southern Medical University, China, Guangzhou Panyu Central Hospital, People's Hospital of Yangjiang, Shenzhen People's Hospital, Longyan First Hospital, Affiliated to Fujian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
Detailed Description
The project of Guangdong GAMI(reGional network for Acute Myocardial Infarction) is being conducted during 2015-2019 in eight districts with diverse economic development across southern China (Integrated care model was conducted in four regions, which mainly included community public education, non primary-PCI capable centre and referral system improvement, and inhospital green-channal optimization for primary-PCI capable centre. Other four centers were underwent usual care of acute myocardial infacrtion public and medical health service). All the ST-segment elevation myocardial infarction (STEMI) patients admitted in the hospital within 30 days from the symptom onset were enrolled. 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. In addition, laboratory data, medication, and follow-up information were recorded in a database for further analysis regarding the STEMI patient treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Acute Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction
Keywords
Acute myocardial infarction, STEMI, regional network

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
community public education, non-PCI center and emergency transfer system improvement, and inhospital green-channal optimization for PCI center.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care of AMI public and medical health service
Intervention Type
Behavioral
Intervention Name(s)
public education and network construction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Receipt of reperfusion therapy within 12 hoursInfarction patients
Description
The primary outcome was the proportion of patients who received symptom-to-reperfusion treatment within 12 hours.
Time Frame
From 1 month before hospitalization to 24 hours after hospitalization
Secondary Outcome Measure Information:
Title
Onset-to-admission time within 12 hours
Description
The proportion of patients who take a symptom-to-admission period within 12 hours.
Time Frame
From 1 month before hospitalization to 24 hours after hospitalization
Title
Door-to-balloon time within 90 minutes
Description
The proportion of patients who take a door-to-balloon period within 90 minutes.
Time Frame
24 hours
Title
In-hospital clinical outcomes
Description
The incidence of several in-hospital outcomes (in-hospital death; and major adverse cardiac events [MACEs], which mainly included in-hospital death, recurrence of myocardial infarction, and stroke); the length of stay.
Time Frame
30 days
Title
1-year all-cause mortality
Description
Total mortality between 30 days and 1 year after discharge.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All adult patients who suspected diagnosis with STEMI. Exclusion Criteria: patients refused to undergo coronary angiography; patients were confirmed as non-STEMI by coronary angiography or the course of STEMI over 1 month; patients occurred onset STEMI during hospitalization in hospitals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Liang, MD
Organizational Affiliation
Maoming People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianfeng Ye, MD
Organizational Affiliation
Dongguan People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yunzhao Hu, MD
Organizational Affiliation
The first People's Hospital of Shunde, Foshan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wenzhu Zhang, MD
Organizational Affiliation
Guangzhou Panyu Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Longyan First Hospital Affiliated to Fujian Medical University
City
Longyan
State/Province
Fujian
ZIP/Postal Code
364000
Country
China
Facility Name
Dongguan People's Hospital
City
Dongguan
State/Province
Guangdong
ZIP/Postal Code
523000
Country
China
Facility Name
Shunde Hospital of Southern Medical University
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
501080
Country
China
Facility Name
Guangzhou Panyu Central Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
511400
Country
China
Facility Name
Maoming People's Hospital
City
Maoming
State/Province
Guangdong
ZIP/Postal Code
525000
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Facility Name
People's Hospital of Yangjiang
City
Yangjiang
State/Province
Guangdong
ZIP/Postal Code
529500
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26729395
Citation
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.
Results Reference
background
PubMed Identifier
32580976
Citation
Yin X, He Y, Zhang J, Song F, Liu J, Sun G, Liang Y, Ye J, Hu Y, Song M, Chen C, Xu Q, Tan N, Chen J, Liu Y, Liu H, Tian M. Patient-level and system-level barriers associated with treatment delays for ST elevation myocardial infarction in China. Heart. 2020 Oct;106(19):1477-1482. doi: 10.1136/heartjnl-2020-316621. Epub 2020 Jun 24.
Results Reference
background

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reGional Network for Acute Myocardial Infarction

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