Clinical trial NCT03928119: reGional Network for Acute Myocardial Infarction
Official title: Construction of Modern reGional Network for Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Acute Myocardial Infarction
STEMI - ST Elevation Myocardial Infarction
Keywords: Acute myocardial infarction
STEMI
regional network
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Maoming People's Hospital
name: Dongguan People's Hospital
name: Southern Medical University, China
name: Guangzhou Panyu Central Hospital
name: Yangjiang People's Hospital
name: Shenzhen People's Hospital
name: Longyan First Hospital, Affiliated to Fujian Medical University
First posted: 2019-04-25
Enrollment: 7102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Receipt of reperfusion therapy within 12 hoursInfarction patients
timeFrame: From 1 month before hospitalization to 24 hours after hospitalization
Secondary outcomes:
measure: Onset-to-admission time within 12 hours
timeFrame: From 1 month before hospitalization to 24 hours after hospitalization
measure: Door-to-balloon time within 90 minutes
timeFrame: 24 hours
measure: In-hospital clinical outcomes
timeFrame: 30 days
measure: 1-year all-cause mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Longyan
country: China
facility: Longyan First Hospital Affiliated to Fujian Medical University
state: Fujian
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Foshan
country: China
facility: Shunde Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Panyu Central Hospital
state: Guangdong
city: Maoming
country: China
facility: Maoming People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Yangjiang
country: China
facility: People's Hospital of Yangjiang
state: Guangdong
Study officials:
affiliation: Maoming People's Hospital
name: Yan Liang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongguan People's Hospital
name: Jianfeng Ye, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The first People's Hospital of Shunde, Foshan
name: Yunzhao Hu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangzhou Panyu Central Hospital
name: Wenzhu Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.