Artificial Intelligence With Deep Learning and Genes on Cardiovascular Disease

• Conditions: Cardiovascular Diseases
• Interventions: Other: ASCVD risk score

• Registration Number: NCT03877614
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

An association study with large database from electronic medical record system, images, outcome analysis and genetic single nucleotide polymorphism variations by machine learning and artificial intelligence methods in a Taiwanese and Chinese medical center based population

Detailed Description

In recent years, the analysis of big data database combined with computer deep learning has gradually played an important role in biomedical technology. For a large number of medical record data analysis, image analysis, single nucleotide polymorphism difference analysis, etc., all relevant research on the development and application of artificial intelligence can be observed extensively. For clinical indication, patients may receive a variety of cardiovascular routine examination and treatments, such as: cardiac ultrasound, multi-path ECG, cardiovascular and peripheral angiography, intravascular ultrasound and optical coherence tomography, electrical physiology, etc... The current study is for the investigative cardiovascular team to take the advantage that in addition to the examination and treatment the participants should appropriately receive, the investigators can also analyze the individual differences and using the "deep learning methodology" to analyze the difference in physical fitness, therapeutic effectiveness and the consideration in the safety of the treatment. The additional goal of this study is to improve the quality of health care, the realization of cardiovascular "precise medicine" especially with personal difference on genetic variation.

This study will analyze the differences in the individualization of cardiovascular disease between diseases and other subjects to further improve the quality of care for clinical patients. By using artificial intelligence deep learning system, the investigators hope to not only improve the diagnostic rate and also gain more accurately predict the patient's recovery, improve medical quality in the near future.

Study Timeline

• Study Start: 2018-08-28
• Status Verified: 2019-03
• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-13
• Last Update Submitted: 2019-03-13
• Study First Posted: 2019-03-15
• Last Update Posted: 2019-03-15
• Primary Completion: 2021-12
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Patients' selection criteria and enrollment plan:

We will enroll subjects from either cardiovascular clinics or inpatients from the National Cheng Kung University Hospital from 2018 to 2021 after the signature of inform consent from patients and their families. The major enrollment criteria include one of the flowing diseases or conditions:

A. Coronary artery disease:

1. History of myocardial infarction

2. Coronary artery disease with computer tomography angiography image study with at least one vessel luminal stenosis >70%

3. Coronary artery stents implantation by hospital-based image database

4. Thallium-201 scan positive/treadmill test positive with additional 2 risk factors, including

   1. Diabetes mellitus
   2. Hypertension
   3. Dyslipidemia
   4. Family history of sudden death, coronary bypass surgery, cerebral vascular attacks (CVA), premature myocardial infarction
   5. Smoking behaviors

B. Congestive heart failure with reduced ejection fraction

1. Echocardiography left ventricular ejection fraction <40%

C. Hypertrophic cardiomyopathy:

1. Left ventricle interventricular septum（IVS) >15 mm
2. Left ventricle mass index> 200gm
3. Apical hypertrophy noted on the report with 4 chamber view

D. Atrial fibrillation

1. Recorded by Holter continuous EKG
2. Recorded by standard 12 leads complete EKG

E. Pulmonary hypertension

1. Echo with systolic pulmonary pressure (sysPAP)> 40 mmHg
2. Diagnosis of idiopathic pulmonary hypertension
3. Under pulmonary hypertension medication

F. Fabry's disease

1. α-Galactosidase (a-GAL) enzyme deficiency
2. Genetic disorder

G. Patient with only risk factors (<3 risk factors), recognized as the comparison group (>500 cases)

1. Diabetes mellitus
2. Hypertension
3. Dyslipidemia
4. Family history of sudden death, coronary bypass surgery, cerebral vascular attacks, premature myocardial infarction
5. Smoking behavior

Exclusion Criteria

• Patients unwilling to be enrolled
• Concentration of DNA collection was inadequate after 3 times of collection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiovascular Low-risk (control) group	ASCVD risk score	Patient with only risk factors with ASCVD score\<10% will be recognized as the comparison group
Cardiovascular high-risk (disease) group	ASCVD risk score	A. Coronary artery disease B. Congestive heart failure with reduced ejection fraction C. Hypertrophic cardiomyopathy D. Atrial fibrillation E. Pulmonary hypertension F. Fabry's disease

Primary Outcome Measures

Name	Time	Method
Major cardiovascular events	5 years	The rate of myocardial infarction, stroke, death, cardiovascular death, heart failure with hospitalization

Secondary Outcome Measures

Name	Time	Method
Lipid profiles	5 years	The percentage changes and response of lipid profile with regular lipid lowering agents
Arrhythmia events	5 years	The rate of arrhythmia associated complications and clinical events, stokes
Recurrent acute coronary events	5 years	The rate of recurrent acute coronary events with hospitalization needed or re-intervention procedures for coronary artery needed
Heart function changes	5 years	parameters and function changes from echocardiography

Trial Locations

Locations (1)

Department of Internal Medicine, National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan