Analysis of Clinical featuRes and Echocardiographic Characteristics for Diagnosis of Infiltrative cardiomyopaThy (ACREDIT): Retrospective Multi-center Observational Study

NCT05108168 | Unknown DMC

• 1 other identifier: 4-2020-1278
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study sought to develop an algorithm by collecting echocardiographic image information and related clinical information capable of quantitatively evaluating changes of the myocardium through machine learning. Moreover, the researchers investigate the usefulness of an algorithm for early diagnosis and differential diagnosis of infiltrative cardiomyopathy.

Conditions

Infiltrative Cardiomyopathy

Outcome Measures

Primary Outcomes (3)

• Sensitivity

  Sensitivity (True Positive Rate) refers to the proportion of those who have the infiltrative cardiomyopathy that received a positive result on the diagnostic algorythm by machine learning.

  until June 30, 2022

• Specificity

  Specificity refers to the proportion of those who do not have the infiltrative cardiomyopathy that received a negative result on the test.

  until June 30, 2022

• Area under the curve of the receiver operation characteristics

  until June 30, 2022

Study Arms (1)

infiltrative cardiomyopathy

infiltrative cardiomyopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

It is important to obtain as large image data as possible to develop an algorithm capable of diagnosing various infiltrative myocardial diseases. Infiltrative cardiomyopathy is a rare disease, and it was reported that the prevalence of cardiac amyloidosis in Korea was 1.91 per 100,000 in 2015.2 In the case of other diseases, there has been no report of the prevalence in Korea, but reports from an overseas report that cardiac sarcoidosis is 2.2 per 100,000, 8 and Fabry disease is 0.9 to 2.5 per 100,000. 9,10 Securing enough data that can be learned to improve machine learning accuracy is not easy because of the scarcity of invasive cardiomyopathy. Furthermore, it is difficult to confirm the disease. Therefore, it is necessary to review and obtain clinical information and echocardiographic image data of as many confirmed patients as possible. This study is a retrospective observational study, and the expected number of target subjects is about 500.

You may not qualify if:

• Selection criteria for screening (1) 18 years old or older (2) Patients with infiltrative cardiomyopathy (the diagnostic name for each of the following diseases) or systemic disease (such as amyloidosis, multiple myeloma, sarcoidosis) (3) Search Period: January 1, 2010-December 31, 2020
• Criteria for enrolling patients
• Patients who are satisfied with at least one of each definition are selected.
• Cardiac amyloidosis1,5,11,12 I. 'Definite': Positive myocardial biopsy (Congo-Red positive) II. 'Probable': One of the following imaging findings along with a positive biopsy of tissues other than myocardium A. Positive DPD / PYP scan Grade 2-3 cardiac uptake B. Echocardiography Symmetrical increase in LV and RV wall thickness Dilated LA and RA Granular appearance of myocardium Pericardial effusion Decreased or normal RQS complex voltage despite increased LV wall thickness C. Cardiac magnetic resonance imaging Diffuse subendocardial late Gd-enhancement Elevated native T1 and ECV value III. 'Possible': Two or more of the above imaging findings are satisfied without biopsy findings, and it is suitable for the diagnosis according to all clinical findings
• Hemochromatosis 17 I. 'Definite': Positive myocardial biopsy Iron deposits within the myocyte II. 'Probable': Non-myocardial tissue biopsy positive or iron overload clinical evidence (such as hereditary hemochromatosis, transfusion-dependent anemia) and the following imaging findings A. Echocardiography Dilated LV with global systolic dysfunction B. Cardiac magnetic resonance imaging Low T2\* value of myocardium
• Etc
• ① Fabry disease18,19 I. 'Definite': Positive myocardial biopsy Enlarged myocytes with clusters of concentric glycolipid (myelinoid bodies) within lysosomes II. 'Probable': A-galactosidase A screening test and X-linked genetic test positive, along with the following echocardiographic findings A. Echocardiography Symmetrical increase in LV and RV wall thickness
• ② Danon disease20 I. 'Definite': Positive for genetic testing or biopsy of myocardial tissue, along with the following echocardiographic findings Symmetrical increase in LV and/or RV wall thickness Decreased LV systolic function
• ③ Cardiac oxalosis1 I. 'Definite': Positive myocardial biopsy II. 'Probable': The following echocardiographic findings along with a history of massive transfusion or positive biopsy of tissues other than myocardium Symmetrical increase in LV and RV wall thickness Patchy, echodense speckled reflection

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital, Division of Cardiology

Seoul, South Korea

RECRUITING

Related Publications (2)

• Seward JB, Casaclang-Verzosa G. Infiltrative cardiovascular diseases: cardiomyopathies that look alike. J Am Coll Cardiol. 2010 Apr 27;55(17):1769-79. doi: 10.1016/j.jacc.2009.12.040.

  PMID: 20413025 BACKGROUND

• van Griethuysen JJM, Fedorov A, Parmar C, Hosny A, Aucoin N, Narayan V, Beets-Tan RGH, Fillion-Robin JC, Pieper S, Aerts HJWL. Computational Radiomics System to Decode the Radiographic Phenotype. Cancer Res. 2017 Nov 1;77(21):e104-e107. doi: 10.1158/0008-5472.CAN-17-0339.

  PMID: 29092951 BACKGROUND

Study Officials

• Hyuk-jae Chang

  Yonsei University Health System, Severance Hospital, Division of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyuk-jae Chang

CONTACT

+82 2-2228-8460; hjchang@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: November 4, 2021
• Study Start: January 4, 2021
• Primary Completion: December 16, 2021
• Study Completion: December 31, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)