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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06062316
Other study ID # xuanwuliuzhi
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 10, 2022
Est. completion date June 1, 2024

Study information

Verified date October 2023
Source Xuanwu Hospital, Beijing
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 4000
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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(+). Exclusion Criteria: - 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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Xuanwu Hospital, Capital Medical University Beijing Xicheng

Sponsors (2)

Lead Sponsor Collaborator
Xuanwu Hospital, Beijing Beijing Institute of Technology

Country where clinical trial is conducted

China, 

References & Publications (24)

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Fernandez-Ruiz I. Machine learning predicts risk in ACS. Nat Rev Cardiol. 2021 Apr;18(4):230. doi: 10.1038/s41569-021-00521-8. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Motwani M, Dey D, Berman DS, Germano G, Achenbach S, Al-Mallah MH, Andreini D, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Chinnaiyan K, Chow BJ, Cury RC, Delago A, Gomez M, Gransar H, Hadamitzky M, Hausleiter J, Hindoyan N, Feuchtner G, Kaufmann PA, Kim YJ, Leipsic J, Lin FY, Maffei E, Marques H, Pontone G, Raff G, Rubinshtein R, Shaw LJ, Stehli J, Villines TC, Dunning A, Min JK, Slomka PJ. Machine learning for prediction of all-cause mortality in patients with suspected coronary artery disease: a 5-year multicentre prospective registry analysis. Eur Heart J. 2017 Feb 14;38(7):500-507. doi: 10.1093/eurheartj/ehw188. — View Citation

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. — View Citation

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. — View Citation

Sanchez-Cabo F, Rossello X, Fuster V, Benito F, Manzano JP, Silla JC, Fernandez-Alvira JM, Oliva B, Fernandez-Friera L, Lopez-Melgar B, Mendiguren JM, Sanz J, Ordovas JM, Andres V, Fernandez-Ortiz A, Bueno H, Ibanez B, Garcia-Ruiz JM, Lara-Pezzi E. Machine Learning Improves Cardiovascular Risk Definition for Young, Asymptomatic Individuals. J Am Coll Cardiol. 2020 Oct 6;76(14):1674-1685. doi: 10.1016/j.jacc.2020.08.017. — View Citation

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. — View Citation

Tan JH, Hagiwara Y, Pang W, Lim I, Oh SL, Adam M, Tan RS, Chen M, Acharya UR. Application of stacked convolutional and long short-term memory network for accurate identification of CAD ECG signals. Comput Biol Med. 2018 Mar 1;94:19-26. doi: 10.1016/j.compbiomed.2017.12.023. Epub 2018 Jan 2. — View Citation

Than MP, Pickering JW, Sandoval Y, Shah ASV, Tsanas A, Apple FS, Blankenberg S, Cullen L, Mueller C, Neumann JT, Twerenbold R, Westermann D, Beshiri A, Mills NL; MI3 Collaborative. Machine Learning to Predict the Likelihood of Acute Myocardial Infarction. Circulation. 2019 Sep 10;140(11):899-909. doi: 10.1161/CIRCULATIONAHA.119.041980. Epub 2019 Aug 16. — View Citation

Tokodi M, Schwertner WR, Kovacs A, Toser Z, Staub L, Sarkany A, Lakatos BK, Behon A, Boros AM, Perge P, Kutyifa V, Szeplaki G, Geller L, Merkely B, Kosztin A. Machine learning-based mortality prediction of patients undergoing cardiac resynchronization therapy: the SEMMELWEIS-CRT score. Eur Heart J. 2020 May 7;41(18):1747-1756. doi: 10.1093/eurheartj/ehz902. — View Citation

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. — View Citation

* Note: There are 24 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 1year
Secondary 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.
1year
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