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Acute Myocardial InfarctionNCT03297164

Incidence Rate of Heart Failure After Acute Myocardial Infarction With Optimal Treatment

An observational study of Acute Myocardial Infarction and Heart Failure, run by Harbin Medical University at 19 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study is to build a multi-center, prospective and regionally representative acute myocardial infarction(AMI) cohort，and build a study platform for heart failure caused by AMI; To explore the 1 year incidence rate of heart failure after AMI given the optimized treatment and the treatment model… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction, Heart Failure
How many people
12,043 participants
Where
19 sitesChina
Study dates
21 Dec 2017to 30 Jun 2021
Phase
Observational
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

Study population: acute myocadial infarction

Who may be able to join

  • age≥18 years
  • diagnosed acute myocardial infarction
  • signed the informed consent form

Who cannot join

  • AMI is caused by surgery, trauma, gastrointestinal bleeding or complications of PCI;
  • AMI occurred in patients who have been hospitalized for other reasons;
  • patients with previous history of chronic heart failure;
  • researchers judging that patient's compliance was poor and could not complete the study according to the requirements.
  • life expectancy is less than 12 months;
  • heart transplant patients;
  • patients with tumors;

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • Beijing An Zhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029

  • Peking Univerisity People'Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130000

  • Third Military Medical University

    Chongqing, Sichuan

  • the second affiliated hospital of Dalian medical university

    Dalian, Liaoning

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang, 163001

  • Guangdong general hospital

    Guangzhou, Guangdong

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • The first affiliated hospital of Guangxi medical university

    Nanning, Guangxi, 530021

  • Shenyang military district general hospital of the people's liberation army

    Shenyang, Liaoning

  • Second hospital of hebei medical university

    Shijiazhuang, Hebei

  • The General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • The first affiliated hospital of military medical university

    Xi’an, Shanxi

  • The first affiliated hospital of Zhengzhou medical university

    Zhengzhou, Henan

Other trials in China

About this study

Official title: One Year Incidence Rate of Heart Failure After Acute Myocardial Infarction With Optimal Treatment-A Prospective,Multicenter,Cohort Study

The main purpose of this study is to build a multi-center, prospective and regionally representative acute myocardial infarction(AMI) cohort，and build a study platform for heart failure caused by AMI; To explore the 1 year incidence rate of heart failure after AMI given the optimized treatment and the treatment model affecting the incidence rate of heart failure, and finally to reduce the incidence rate of heart failure by 5%.

Read the detailed description

the study aim to enroll 12000 acute myocardial infartion (AMI) patients, including ST-segment elevation myocardial infarction (STEMI) and non ST-segment elevation myocardial infarction (NSETMI), Patients were divided into two groups(optimized group and un-optimized group) according to treatment models they accepted in 20 reginally representative hosptials of China. whether optimizaed or not is judged by 4 four aspects,including emergency treatment procedure, pre-infusion medication, reperfusion strategy selection, and early rehabilitation after reperfusion.Patients were followed at 1 month, 6 months and 12 months. The physical condition and clinical events(heart failure, death, re-infarction, revascularization, apoplexy, malignant arrhythmias, bleeding events, other adverse events)were collected at follow up.

Keywords
acute myocardial infarction, heart failure, optimized treatment
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03297164
Study groupRoleWhat they receive
optimized groupthe patients in this group have been given the suggestive treatment from guideline.
un-optimized groupthe patients in this group have not been given the suggestive treatment from guideline.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence rate of heart failure

    incidence rate of heart failure of acute myocardial infarction at 12th month

    Measured: 12th month after diacharge

Secondary outcomes (3)

  1. MACCE rate

    the major adverse cardiac celebral events including death,reinfarction,

    Measured: 12th month after diacharge

  2. bleeding rate

    the incidence rate of bleeding

    Measured: 12th month after diacharge

  3. severe adverse drug reactions

    severe adverse drug reactions at 12th month

    Measured: 12th month after diacharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2017
  2. Study start21 Dec 2017
  3. Primary completion4 Dec 2020
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
12,043 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03297164
Sponsor's protocol ID
2016YFC1301101
Status last verified
Sep 2021
First submitted
26 Sep 2017
Last updated
1 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hou X, Liu J, Zhang J, Wang X, Liu Q, Wang S, Yang X, Zhang Y, Zhang W, Chen S, Sun Y, Wu J. Risk factors and assessment system for cardiogenic death and stroke in patients with premature acute myocardial infarction. Heart Lung. 2026 May-Jun;77:102716. doi: 10.1016/j.hrtlng.2025.102716. Epub 2026 Jan 6.

    PubMed 41500028

  • Wu X, Wang S, Cui H, Zheng X, Hou X, Wang Z, Li Q, Liu Q, Cao T, Zheng Y, Wu J, Yu B. Machine learning-based return-to-work assessment system for acute myocardial infarction patients within 12 months. Heart Lung. 2025 Sep-Oct;73:19-25. doi: 10.1016/j.hrtlng.2025.04.020. Epub 2025 Apr 20.

    PubMed 40258309

  • Wang J, Li Z, Yang G, Fang C, Yin Y, Zheng Z, Wang H, Fang S, Dai J, Wang S, Yang S, Yu B. Pseudo-targeted metabolic profile differences between emergency patients with type 1 and type 2 myocardial infarction diagnosed by optical coherence tomography. Clin Chim Acta. 2024 Feb 1;554:117745. doi: 10.1016/j.cca.2023.117745. Epub 2024 Jan 6.

    PubMed 38185283

  • Lang X, Zhao B, Fang S, Li L, Li Z, Wu N, Zhang Y, Xing L, Li Y, Zhang Y. Higher Peripheral Thyroid Sensitivity Is Linked to a Lower Risk of Heart Failure After Acute Myocardial Infarction. J Clin Endocrinol Metab. 2023 Oct 18;108(11):2950-2960. doi: 10.1210/clinem/dgad240.

    PubMed 37104944

  • Zeng M, Zhao C, Bao X, Liu M, He L, Xu Y, Meng W, Qin Y, Weng Z, Yi B, Zhang D, Wang S, Luo X, Lv Y, Chen X, Sun Q, Feng X, Gao Z, Sun Y, Demuyakor A, Li J, Hu S, Guagliumi G, Mintz GS, Jia H, Yu B. Clinical Characteristics and Prognosis of MINOCA Caused by Atherosclerotic and Nonatherosclerotic Mechanisms Assessed by OCT. JACC Cardiovasc Imaging. 2023 Apr;16(4):521-532. doi: 10.1016/j.jcmg.2022.10.023. Epub 2022 Dec 14.

    PubMed 36648054

  • Li L, Zhang X, Wang Y, Yu X, Jia H, Hou J, Li C, Zhang W, Yang W, Liu B, Lu L, Tan N, Yu B, Li K. A Novel Risk Score to Predict In-Hospital Mortality in Patients With Acute Myocardial Infarction: Results From a Prospective Observational Cohort. Front Cardiovasc Med. 2022 Apr 7;9:840485. doi: 10.3389/fcvm.2022.840485. eCollection 2022.

    PubMed 35463775

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Infarction and Heart Failure, run by Harbin Medical University at 19 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

incidence rate of heart failure (time frame: 12th month after diacharge). 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 NCT03297164, which also lists 6 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 Oct 2021.

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