reGional Network for Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— GAMI  

Official title:

Construction of Modern reGional Network for Acute Myocardial Infarction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03928119
• Other study ID #: 2014B070706010
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: February 28, 2024

Study information

• Verified date: May 2022
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7102
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
China	Dongguan People's Hospital	Dongguan	Guangdong
China	Shunde Hospital of Southern Medical University	Foshan	Guangdong
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Guangzhou Panyu Central Hospital	Guangzhou	Guangdong
China	Longyan First Hospital Affiliated to Fujian Medical University	Longyan	Fujian
China	Maoming People's Hospital	Maoming	Guangdong
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	People's Hospital of Yangjiang	Yangjiang	Guangdong

Sponsors (8)

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

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Onset-to-admission time within 12 hours	The proportion of patients who take a symptom-to-admission period within 12 hours.	From 1 month before hospitalization to 24 hours after hospitalization
Secondary	Door-to-balloon time within 90 minutes	The proportion of patients who take a door-to-balloon period within 90 minutes.	24 hours
Secondary	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.	30 days
Secondary	1-year all-cause mortality	Total mortality between 30 days and 1 year after discharge.	1 year