- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03928119
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
Status
Active, not recruiting
Conditions
Intervention / 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.
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
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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:
- 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
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.
Collaborators
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.
General Publications
- 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014B070706010
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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