Coronary Heart DiseaseGAMINCT03928119
reGional Network for Acute Myocardial Infarction
A study testing public education and network construction in people with Coronary Heart Disease and Acute Myocardial Infarction, run by Guangdong Provincial People's Hospital at 8 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Acute Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- public education and network construction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,102 participants
- Where
- 8 sitesChina
- Study dates
- 1 Aug 2015to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients who suspected diagnosis with STEMI.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Dongguan People's Hospital
Dongguan, Guangdong, 523000
Shunde Hospital of Southern Medical University
Foshan, Guangdong, 528000
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 501080
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, 511400
Longyan First Hospital Affiliated to Fujian Medical University
Longyan, Fujian, 364000
Maoming People's Hospital
Maoming, Guangdong, 525000
Shenzhen People's Hospital
Shenzhen, Guangdong, 518000
People's Hospital of Yangjiang
Yangjiang, Guangdong, 529500
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Heart Disease, Acute Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction
- Being tested
- public education and network construction
- Keywords
- Acute myocardial infarction, STEMI, regional network
- Medical subject headings
- Coronary Disease, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
public education and network constructionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | community public education, non-PCI center and emergency transfer system improvement, and inhospital green-channal optimization for PCI center. Receives: Behavioral: public education and network construction |
| Control group | No intervention | Usual care of AMI public and medical health service |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 1 month before hospitalization to 24 hours after hospitalization
Secondary outcomes (4)
Onset-to-admission time within 12 hours
The proportion of patients who take a symptom-to-admission period within 12 hours.
Measured: From 1 month before hospitalization to 24 hours after hospitalization
Door-to-balloon time within 90 minutes
The proportion of patients who take a door-to-balloon period within 90 minutes.
Measured: 24 hours
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.
Measured: 30 days
1-year all-cause mortality
Total mortality between 30 days and 1 year after discharge.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start1 Aug 2015
- Primary completion28 Feb 2020
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 7,102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Maoming People's Hospital, Dongguan People's Hospital, Southern Medical University, China, Guangzhou Panyu Central Hospital, Yangjiang People's Hospital, Shenzhen People's Hospital, Longyan City First Hospital
- Responsible party
- Principal investigator, Jiyan Chen, Guangdong Provincial People's Hospital
- Investigators
- Yan Liang, MD, Principal investigator, Maoming People's HospitalJianfeng Ye, MD, Principal investigator, Dongguan People's HospitalYunzhao Hu, MD, Principal investigator, The first People's Hospital of Shunde, FoshanWenzhu Zhang, MD, Principal investigator, Guangzhou Panyu Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928119
- Sponsor's protocol ID
- 2014B070706010
- Acronym
- GAMI
- Status last verified
- May 2022
- First submitted
- 21 Apr 2019
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26729395Yin 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.
PubMed 32580976Liu 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. 2026 Aug 12;112(17):965-973. doi: 10.1136/heartjnl-2024-324155.
PubMed 40930595
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Modern reGional Network for Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03928119
- Acronym / sponsor ID
- GAMI / 2014B070706010
- Conditions
- Coronary Heart Disease, Acute Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction
- Keywords
- Acute myocardial infarction, STEMI, regional network
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,102 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Maoming People's Hospital, Dongguan People's Hospital, Southern Medical University, China, Guangzhou Panyu Central Hospital, Yangjiang People's Hospital, Shenzhen People's Hospital, Longyan City First Hospital
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: public education and network constructioncommunity public education, non-PCI center and emergency transfer system improvement, and inhospital green-channal optimization for PCI center. |
| Control group | No intervention | –Usual care of AMI public and medical health service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients who suspected diagnosis with STEMI.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| public education and network constructionPublication 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. | Behavioural | Intervention group |
Primary outcome
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.
4 secondary outcomes
Onset-to-admission time within 12 hours
Time frame: From 1 month before hospitalization to 24 hours after hospitalization
Door-to-balloon time within 90 minutes
Time frame: 24 hours
In-hospital clinical outcomes
Time frame: 30 days
1-year all-cause mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Background: PubMed 26729395Lu 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.
- Background: PubMed 32580976Yin 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.
- Derived from this study: PubMed 40930595Liu 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. 2026 Aug 12;112(17):965-973. doi: 10.1136/heartjnl-2024-324155.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing public education and network construction in people with Coronary Heart Disease and Acute Myocardial Infarction, run by Guangdong Provincial People's Hospital at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of reperfusion therapy within 12 hoursInfarction patients (time frame: From 1 month before hospitalization to 24 hours after hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03928119, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.