reGional Network for Acute Myocardial Infarction

Overview

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.

Full Title of Study: “Construction of Modern reGional Network for Acute Myocardial Infarction”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 28, 2020

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.

Interventions

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.
  • 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.
  • 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.
  • 1-year all-cause mortality
    • Time Frame: 1 year
    • Total mortality between 30 days and 1 year after discharge.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangdong Provincial People’s Hospital
  • Collaborator
    • Maoming People’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jiyan Chen, Professor – Guangdong Provincial People’s Hospital
  • Overall Official(s)
    • Yan Liang, MD, Principal Investigator, Maoming People’s Hospital
    • Jianfeng Ye, MD, Principal Investigator, Dongguan People’s Hospital
    • Yunzhao Hu, MD, Principal Investigator, The first People’s Hospital of Shunde, Foshan
    • Wenzhu Zhang, MD, Principal Investigator, Guangzhou Panyu Central Hospital

References

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.

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.

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