AI-enabled Screening and Diagnosis of Cardiomyopathies Using Coronary CTA

NCT06748261 | Not Yet Recruiting DMC

• 1 other identifier: ZS-CCTAI
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational and diagnostic study is to develop and validate an artificial intelligence assisted approach for coronary computer tomography angiography-(CCTA)-based screening and diagnosis of cardiomyopathies in patients with suspected coronary artery diseases. This study aims to develop a computerized CCTA interpretation using artificial intelligence for multi-label classification task to assist cardiomyopathy diagnosis in the clinical workflow.

Conditions

Cardiovascular Diseases; Hypertrophic Cardiomyopathy (HCM); Dilated Cardiomyopathy (DCM); Restrictive Cardiomyopathy; Amyloid Cardiomyopathy; Ischemic Cardiomyopathy; Arrhythmogenic Right Ventricular Cardiomyopathy; Myocarditis; Cardiomyopathies

Keywords

Cardiac computer tomography angiography; Cardiomyopathies; Artificial intelligence; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance

  The performance of the AI models is evaluated by assessing their sensitivity, specificity, precision and F1 score (harmonic mean of the predictive positive value and sensitivity), with two-sided 95% CIs, as well as the AUC of the ROC with two-sided CIs. The F1 score is complementary to the AUC, which is particularly useful in the setting of multiclass prediction and less sensitive than the AUC in settings of class imbalance. For an aggregate measure of model performance, the investigators compute the class frequency-weighted mean for the F1 score and the AUC. Other diagnostic performance assessing metrics include true-positive rate, true-negative rate, false-positive rate, false-negative rate, precision, sensitivity (recall), specificity, positive predictive value, and negative predictive value.

  CCTA examination before surgical or interventional treatments.

Study Arms (2)

Cardiomyopathy cohort

Patients who have underwent CCTA examination and have recorded diagnosis of cardiomyopathy are enrolled in the cardiomyopathy cohort. Clinical diagnosis of cardiomyopathies based on patients' complete electrical medical record (EMR), encompassing clinical presentations, family history, laboratory results, ECG, echocardiogram, all available imaging assessments (if any, i.e. cardiac magnetic resonance, single-photon emission computed tomography, and invasive coronary angiography), and myocardial biopsy (if any). Clinical diagnoses are retrieved from (EMR) and used as ground truth for AI-assisted CCTA-based screening and diagnostic model developing.

Diagnostic Test: CCTAI model

Control cohort

Participants who have CCTA examination are recruited in the control cohort given that his or her medical record rules out cardiovascular diseases (including cardiomyopathy, history of myocardial infarction, history of cardiac surgery, stent implantation, ICD implantation and so on) and secondary cardiac abnormalities due to systemic diseases.

Diagnostic Test: CCTAI model

Interventions

CCTAI model DIAGNOSTIC_TEST

Using a derivative sub-cohort, the investigators aim to first develop an CCTA-based AI-assisted (CCTAI) screening model to distinguish patients with cardiac abnormalities from those normal controls. Second, the investigators target at developing a CCTAI diagnostic model with multi-classification output of cardiomyopathy diagnosis. Both models will be tested in internal validation cohort and external validation cohort.

Cardiomyopathy cohort; Control cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive candidates have at least one CCTA between 1/1/2014 and 31/12/2024 will be collected.

You may qualify if:

• A clinical diagnosis of cardiomyopathies, including hypertrophic cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy, cardiac amyloidosis, myocarditis, arrhythmogenic right ventricular cardiomyopathy, and coronary artery disease/ischemic heart disease.
• At least one CCTA before surgery or implantable device treatment.

You may not qualify if:

• No recorded diagnosis of cardiomyopathy or undetermined type of cardiomyopathy.
• A clinical diagnosis of secondary cardiac abnormalities due to other organic or systemic diseases.
• Surgery or implantable device treatment before CCTA examination.
• Control cohort:

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Cardiovascular Diseases; Cardiomyopathy, Hypertrophic; Cardiomyopathy, Dilated; Cardiomyopathy, Restrictive; Amyloid Neuropathies, Familial; Arrhythmogenic Right Ventricular Dysplasia; Myocarditis; Cardiomyopathies; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chenguang Li, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junbo Ge, MD, PhD

CONTACT

008664041990; jbge@zs-hospital.sh.cn

Chenguang Li, MD, PhD

CONTACT

li.chenguang@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 27, 2024
• Study Start: December 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share