reGional Network for Acute Myocardial Infarction (GAMI)

May 26, 2022 updated by: Jiyan Chen, Guangdong Provincial People's Hospital

Construction of Modern reGional Network for Acute Myocardial Infarction

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

7102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Fujian
      • Longyan, Fujian, China, 364000
        • Longyan First Hospital Affiliated to Fujian Medical University
    • Guangdong
      • Dongguan, Guangdong, China, 523000
        • Dongguan People's Hospital
      • Foshan, Guangdong, China, 528000
        • Shunde Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 511400
        • Guangzhou Panyu Central Hospital
      • Guangzhou, Guangdong, China, 501080
        • Guangdong Provincial People's Hospital
      • Maoming, Guangdong, China, 525000
        • Maoming People's Hospital
      • Shenzhen, Guangdong, China, 518000
        • Shenzhen People's Hospital
      • Yangjiang, Guangdong, China, 529500
        • People's Hospital of Yangjiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
community public education, non-PCI center and emergency transfer system improvement, and inhospital green-channal optimization for PCI center.
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.
No Intervention: Control group
Usual care of AMI public and medical health service

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receipt of reperfusion therapy within 12 hoursInfarction patients
Time Frame: From 1 month before hospitalization to 24 hours after hospitalization
The primary outcome was the proportion of patients who received symptom-to-reperfusion treatment within 12 hours.
From 1 month before hospitalization to 24 hours after hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset-to-admission time within 12 hours
Time Frame: From 1 month before hospitalization to 24 hours after hospitalization
The proportion of patients who take a symptom-to-admission period within 12 hours.
From 1 month before hospitalization to 24 hours after hospitalization
Door-to-balloon time within 90 minutes
Time Frame: 24 hours
The proportion of patients who take a door-to-balloon period within 90 minutes.
24 hours
In-hospital clinical outcomes
Time Frame: 30 days
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.
30 days
1-year all-cause mortality
Time Frame: 1 year
Total mortality between 30 days and 1 year after discharge.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yan Liang, MD, Maoming People's Hospital
  • Principal Investigator: Jianfeng Ye, MD, Dongguan People's Hospital
  • Principal Investigator: Yunzhao Hu, MD, The first People's Hospital of Shunde, Foshan
  • Principal Investigator: Wenzhu Zhang, MD, Guangzhou Panyu Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

February 28, 2020

Study Completion (Anticipated)

February 28, 2024

Study Registration Dates

First Submitted

April 21, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 25, 2019

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 26, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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