NCT03928119

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,102

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

4.6 years

First QC Date

April 21, 2019

Last Update Submit

May 26, 2022

Conditions

Keywords

Acute myocardial infarctionSTEMIregional network

Outcome Measures

Primary Outcomes (1)

  • 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.

    From 1 month before hospitalization to 24 hours after hospitalization

Secondary Outcomes (4)

  • Onset-to-admission time within 12 hours

    From 1 month before hospitalization to 24 hours after hospitalization

  • Door-to-balloon time within 90 minutes

    24 hours

  • In-hospital clinical outcomes

    30 days

  • 1-year all-cause mortality

    1 year

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: public education and network construction

Control group

NO INTERVENTION

Usual care of AMI public and medical health service

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients who suspected diagnosis with STEMI.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Longyan First Hospital Affiliated to Fujian Medical University

Longyan, Fujian, 364000, China

Location

Dongguan People's Hospital

Dongguan, Guangdong, 523000, China

Location

Shunde Hospital of Southern Medical University

Foshan, Guangdong, 528000, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 501080, China

Location

Guangzhou Panyu Central Hospital

Guangzhou, Guangdong, 511400, China

Location

Maoming People's Hospital

Maoming, Guangdong, 525000, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518000, China

Location

People's Hospital of Yangjiang

Yangjiang, Guangdong, 529500, China

Location

Related Publications (3)

  • 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.

    PMID: 26729395BACKGROUND
  • 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.

    PMID: 32580976BACKGROUND
  • Liu Y, Liu J, Liang Y, Ye J, Hu Y, Chen L, Dong S, Huang X, Song M, Meng R, Zheng X, He Y, Zhang J, Yin X, Chen S, Tan N, Tian M, Chen J. Effect of an integrated care model on ST-segment elevation myocardial infarction management in China: a prospective, multicentre, non-randomised controlled study. Heart. 2025 Sep 9:heartjnl-2024-324155. doi: 10.1136/heartjnl-2024-324155. Online ahead of print.

MeSH Terms

Conditions

Coronary DiseaseST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2019

First Posted

April 25, 2019

Study Start

August 1, 2015

Primary Completion

February 28, 2020

Study Completion

February 28, 2024

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations