Clinical trial: Artificial Intelligence With Deep Learning and Genes on Cardiovascular Disease (NCT03877614)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 23-year-old man comes to the emergency department following an episode of syncope.  He was working out when he felt dizzy and passed out without head injury.  He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions.  The patient does not use tobacco, alcohol, or illicit drugs.  His father died suddenly at age 35.  Vital signs are within normal limits.  On physical examination, the patient has a harsh systolic murmur.  The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy.

Patient description (patient's own words): I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average.

Does the patient match the trial criteria? Entailment