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Myocardial InfarctionNCT06062316

Warning Model of Myocardial Remodeling After Acute Myocardial Infarction Using Multimodal Feature Structure Technology

An observational study of Myocardial Infarction, run by Xuanwu Hospital, Beijing at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Acute myocardial infarction (AMI) is one of the most important diseases threatening human life. The existing MI prognosis prediction scales mostly predict the incidence of death, recurrent MI and heart failure through 6-8 clinical text indicators, and the data are collected relatively simply. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Myocardial Infarction
How many people
4,000 participants
Where
1 siteChina
Study dates
10 Oct 2022to 1 Jun 2024
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Criteria for the diagnosis of acute myocardial infarction: increased or decreased cardiac biomarkers (preferably cTn), at least once exceeding the 99th percentile of the upper reference value, cut-off variability ≤10%, and at least one evidence of myocardial ischemia (including symptoms, electrocardiographic ischemic changes, pathological Q-waves, or imaging evidence).

Who may be able to join

  • 1.Patients with acute myocardial infarction, aged 18-80 years; 2.The time from onset to treatment is less than 72h 3.Myocardial enzyme Tni/Tnt(+).

Who cannot join

  • 1.Patients with malignant tumors; 2.Patients who could not receive conventional treatment 3.Patients who did not receive coronary angiography, lacking anatomical and imaging data; 4.Patients who have undergone cardiac surgery (except coronary artery bypass surgery)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuanwu Hospital, Capital Medical University

    Beijing, Xicheng, 100000

Other trials in China

About this study

Official title: Early Warning Model of Myocardial Remodeling After Acute Myocardial Infarction Based on Multimodal Feature Structure Technology

Acute myocardial infarction (AMI) is one of the most important diseases threatening human life. The existing MI prognosis prediction scales mostly predict the incidence of death, recurrent MI and heart failure through 6-8 clinical text indicators, and the data are collected relatively simply. Myocardial remodeling, as an adverse pathological change that can start and continue to progress in the early stage after myocardial infarction, is the main pathological mechanism of heart failure and death. However, there is no quantitative early-warning model of myocardial remodeling, and the clinical guidance of early intervention is lacking.

Our previous study found that cardiac magnetic resonance imaging can accurately quantify the necrotic area and recoverable myocardium in the edematous myocardium after myocardial infarction. In this study, machine learning algorithm, variable convolution network (DCN) and capsule network (capsnet) are used to build a new neural network architecture. Structural feature extraction of multi-modal clinical image data such as MRI and ultrasound is realized. Combined with the established database of 3000 patients with myocardial infarction, the multimodal feature matrix will be constructed, and a variety of classifiers such as support vector machine (SVM) and random forest (RF) will be used for quantitative prediction of myocardial remodeling, and the effects of different classifiers were evaluated. It is expected that this project will establish a quantitative early warning model of myocardial remodeling after acute myocardial infarction in line with the characteristics of Chinese people. The same type of data outside the database will be used for verification to establish an efficient and stable early warning model.

Keywords
Computer aided diagnosis, Myocardial Remodeling, Early warning model, Myocardial infarction, MRI
Medical subject headings
Myocardial Infarction

What is being measured

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

  1. Novel convolutional neural network algorithm and cardiac magnetic resonance imaging to evaluate the occurrence of myocardial remodeling.remodeling after myocardial infarction.

    (Quantitative characterization of myocardial remodeling, cardiac magnetic resonance imaging quantifying necrotic areas and recoverable myocardium within the edematous myocardium after myocardial infarction).

    Measured: 1year

Secondary outcomes (1)

  1. The multi-dimensional indexes of existing database were compared with the location and course of myocardial remodeling by artificial intelligence method Degree of correlation analysis.

    Through the new Deformable Convolutional Capsule network that has been developed The Networks (DCCN) study focused on the existing clinical and imaging comprehensive database of patients with acute myocardial infarction Machine learning was performed on the data to complete the extraction of relevant features and logical relationship analysis of myocardial remodeling after myocardial infarction.

    Strong correlation features were screened.

    Measured: 1year

Timeline

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

  1. First posted2 Oct 2023
  2. Study start10 Oct 2022
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jun 2024 (estimated)

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
4,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06062316
Sponsor's protocol ID
xuanwuliuzhi
Status last verified
Oct 2023
First submitted
17 Sep 2023
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Moran AE, Forouzanfar MH, Roth GA, Mensah GA, Ezzati M, Murray CJ, Naghavi M. Temporal trends in ischemic heart disease mortality in 21 world regions, 1980 to 2010: the Global Burden of Disease 2010 study. Circulation. 2014 Apr 8;129(14):1483-92. doi: 10.1161/CIRCULATIONAHA.113.004042. Epub 2014 Feb 26.

    PubMed 24573352

  • Abuomara HZA, Hassan OM, Rashid T, Baraka M. Myocardial performance index as an echocardiographic predictor of early in-hospital heart failure during first acute anterior ST-elevation myocardial infarction. Egypt Heart J. 2018 Jun;70(2):71-75. doi: 10.1016/j.ehj.2017.12.001. Epub 2017 Dec 24.

    PubMed 30166885

  • Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2.

    PubMed 23281415

  • Hendriks T, Schurer RAJ, Al Ali L, van den Heuvel AFM, van der Harst P. Left ventricular restoration devices post myocardial infarction. Heart Fail Rev. 2018 Nov;23(6):871-883. doi: 10.1007/s10741-018-9711-2.

    PubMed 29770903

  • Iborra-Egea O, Galvez-Monton C, Roura S, Perea-Gil I, Prat-Vidal C, Soler-Botija C, Bayes-Genis A. Mechanisms of action of sacubitril/valsartan on cardiac remodeling: a systems biology approach. NPJ Syst Biol Appl. 2017 Apr 18;3:12. doi: 10.1038/s41540-017-0013-4. eCollection 2017.

    PubMed 28649439

  • McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.

    PubMed 25176015

  • Seferovic PM, Fragasso G, Petrie M, Mullens W, Ferrari R, Thum T, Bauersachs J, Anker SD, Ray R, Cavusoglu Y, Polovina M, Metra M, Ambrosio G, Prasad K, Seferovic J, Jhund PS, Dattilo G, Celutkiene J, Piepoli M, Moura B, Chioncel O, Ben Gal T, Heymans S, Jaarsma T, Hill L, Lopatin Y, Lyon AR, Ponikowski P, Lainscak M, Jankowska E, Mueller C, Cosentino F, Lund LH, Filippatos GS, Ruschitzka F, Coats AJS, Rosano GMC. Heart Failure Association of the European Society of Cardiology update on sodium-glucose co-transporter 2 inhibitors in heart failure. Eur J Heart Fail. 2020 Nov;22(11):1984-1986. doi: 10.1002/ejhf.2026. Epub 2020 Oct 27.

    PubMed 33068051

  • Pasternak B, Ueda P, Eliasson B, Svensson AM, Franzen S, Gudbjornsdottir S, Hveem K, Jonasson C, Wintzell V, Melbye M, Svanstrom H. Use of sodium glucose cotransporter 2 inhibitors and risk of major cardiovascular events and heart failure: Scandinavian register based cohort study. BMJ. 2019 Aug 29;366:l4772. doi: 10.1136/bmj.l4772.

    PubMed 31467044

  • West R, Jones D. Cardiac rehabilitation and mortality reduction after myocardial infarction: the emperor's new clothes? Evidence against cardiac rehabilitation. Heart. 2013 Jul;99(13):911-3. doi: 10.1136/heartjnl-2013-303705. Epub 2013 May 4.

    PubMed 23644409

  • Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044.

    PubMed 26764059

  • Milani RV, Lavie CJ. Impact of cardiac rehabilitation on depression and its associated mortality. Am J Med. 2007 Sep;120(9):799-806. doi: 10.1016/j.amjmed.2007.03.026.

    PubMed 17765050

  • Karuzas A, Rumbinaite E, Verikas D, Ptasinskas T, Muckiene G, Kazakauskaite E, Zabiela V, Jurkevicius R, Vaskelyte JJ, Zaliunas R, Zaliaduonyte-Peksiene D. Accuracy of three-dimensional systolic dyssynchrony and sphericity indexes for identifying early left ventricular remodeling after acute myocardial infarction. Anatol J Cardiol. 2019 Jun;22(1):13-20. doi: 10.14744/AnatolJCardiol.2019.02844.

    PubMed 31264652

  • Kagiyama N, Shrestha S, Cho JS, Khalil M, Singh Y, Challa A, Casaclang-Verzosa G, Sengupta PP. A low-cost texture-based pipeline for predicting myocardial tissue remodeling and fibrosis using cardiac ultrasound. EBioMedicine. 2020 Apr;54:102726. doi: 10.1016/j.ebiom.2020.102726. Epub 2020 Apr 6.

    PubMed 32268274

  • Chirinos JA, Sardana M, Ansari B, Satija V, Kuriakose D, Edelstein I, Oldland G, Miller R, Gaddam S, Lee J, Suri A, Akers SR. Left Atrial Phasic Function by Cardiac Magnetic Resonance Feature Tracking Is a Strong Predictor of Incident Cardiovascular Events. Circ Cardiovasc Imaging. 2018 Dec;11(12):e007512. doi: 10.1161/CIRCIMAGING.117.007512.

    PubMed 30562112

  • Ranka S, Reddy M, Noheria A. Artificial intelligence in cardiovascular medicine. Curr Opin Cardiol. 2021 Jan;36(1):26-35. doi: 10.1097/HCO.0000000000000812.

    PubMed 33060388

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction, run by Xuanwu Hospital, Beijing at 1 site 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 1 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 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Novel convolutional neural network algorithm and cardiac magnetic resonance imaging to evaluate the occurrence of myocardial remodeling.remodeling after myocardial infarction. (time frame: 1year). 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 NCT06062316, which also lists 25 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 30 Apr 2024.

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