Clinical trial NCT06748261: AI-enabled Screening and Diagnosis of Cardiomyopathies Using Coronary CTA
Official title: Artificial Intelligence-enabled Screening and Diagnosis of Cardiomyopathies Using Coronary Computer Tomography Angiography
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive candidates have at least one CCTA between 1/1/2014 and 31/12/2024 will be collected.

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.

Detailed description: Cardiovascular diseases (CVD) are the leading causes of death and disability worldwide. With coronary artery disease accounting for a large proportion of CVD disease burden, coronary computer tomography angiography (CCTA) has become widely used for a comprehensive assessment of the total coronary atherosclerotic burden. In contrast, cardiac magnetic resonance (CMR) remains the gold standard for evaluating and diagnosing cardiomyopathies. However, clinical application of CMR has been hindered by the time and cost of examination and shortage of qualified doctors and staff. Consequently, the value of CCTA in screening and diagnosis in cardiomyopathies warrants further investigation.

The ability of artificial intelligence to learn distinctive features and to recognize characteristic patterns on big data without extensive manual labor makes it highly effective for interpreting CCTA data. Although very few studies investigated the diagnostic value of CCTA for myocardiopathies, which is by far not established or applied in clinical practice by radiologists, automated image analysis has a clear advantage compared to humans by offering objective and uniform solutions. Further, whether a comprehensive, end-to-end, artificial intelligent approach can be used to analyse CCTA for diagnosis multi-classifications of cardiomyopathies remains unknown.

Therefore, this study aims to develop and validate an artificial intelligence assisted approach on CCTA for screening and diagnosis of cardiomyopathies in patients with suspected coronary artery diseases.

Eligibility criteria: Cardiomyopathy cohort:

* Inclusion Criteria:

  1. 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.
  2. At least one CCTA before surgery or implantable device treatment.
* Exclusion Criteria:

  1. No recorded diagnosis of cardiomyopathy or undetermined type of cardiomyopathy.
  2. A clinical diagnosis of secondary cardiac abnormalities due to other organic or systemic diseases.
  3. Surgery or implantable device treatment before CCTA examination.

Control cohort:

* Inclusion Criteria: participants with at least one CCTA examination.
* Exclusion Criteria: clinical diagnosis of cardiovascular diseases (including cardiomyopathy, history of myocardial infarction, history of cardiac surgery, stent implantation, ICD implantation and so on) or secondary cardiac abnormalities due to systemic diseases.

Primary outcomes:
measure: Diagnostic performance
timeFrame: CCTA examination before surgical or interventional treatments.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: Chenguang Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: