Status:
UNKNOWN
A Prospective,Multiple Center,Cohort Study of Prediction Model on Sudden Cardiac Death and Devices Development by Automatic Analysis From 24h Electrocardiogram in China
Lead Sponsor:
Jingfeng Wang
Collaborating Sponsors:
Chinese Academy of Medical Sciences, Fuwai Hospital
Fudan University
Conditions:
Sudden Cardiac Death
Eligibility:
All Genders
18-75 years
Brief Summary
This study is a prospective, multicenter, cohort study. The study will be completed in three phases. The first phase aims to establish SCD PW marker and PW score scoring system 1. Use big data proce...
Detailed Description
This study is a prospective, multicenter, cohort study. The study will be completed in three phases. The first phase is a prospective, multi-center, cohort study of the SCD early warning model. This ...
Eligibility Criteria
Inclusion
- 1\. Patients with recorded ventricular tachycardia, ventricular fibrillation or cardiac arrest meet one of the following conditions:
- survivors with cardiac arrest(including correct electrotherapy of ICD with ATP and electrical cardioversion)owing to non-reversible causes of ventricular fibrillation or hemodynamically unstable sustained ventricular tachycardia.
- Patients who suffer the underlying organic heart disease with spontaneous sustained ventricular tachycardia (including correct ICD therapy including ATP and cardioversion)
- more than 40 days after myocardial infarction , LVEF ≤ 0.35 with grade II or III cardiac function or more than 40 days after myocardial infarction, LVEF ≤ 0.30, with grade I cardiac function;
- non-ischemic cardiomyopathy, grade II or III heart function, LVEF ≤ 0.35;
- hereditary arrhythmia diseases: a group inherited diseases including long QT syndrome, short QT syndrome and Brugada syndrome, etc with arrhythmia, syncope and sudden death as the main clinical manifestations and cardiac gene mutation which encodes ion channels and their regulatory protein as the reason.
- long QT syndrome: electrocardiogram on the surface indicates QTc longer than 440 ms, accompanied by rapid ventricular arrhythmia, clinical symptoms of syncope and sudden death, without organic heart disease, except for acquired QT extension caused by electrolyte disorder and medication.
- short QT syndrome: electrocardiogram on the surface indicates QTc less than 300 ms, accompanied by rapid ventricular arrhythmia, clinical manifestations of syncope and sudden death, without organic heart disease, except for acquired etiology such as electrolyte disturbance and sympathetic stimulation.
- brugada syndrome: electrocardiogram on the surface suggests that the ST segment of leads V1-V3 is descending or saddle-shaped, accompanied by right bundle branch block, rapid ventricular arrhythmia, syncope, and sudden death without organic heart disease and ST-T changes due to other factors.
- catecholamine sensitive ventricular tachycardia: healthy individuals with no cardiac structural abnormalities and normal QTc suffer typical bidirectional, polymorphic ventricular tachycardia during exercise treadmill test or intravenous isoproterenol injection.
- hypertrophic cardiomyopathy: asymmetric ventricular septum hypertrophy\> 15mm, or symmetrical hypertrophy ventricular septum thickness / left ventricular posterior wall thickness \< 1.3 and left ventricular diastolic compliance decreased with or without left intraventricular or outflow obstruction confirmed by examination (including echocardiography, left ventricular angiography, cardiac MRI or cardiac CT, etc.).Heart changes caused by hypertension, aortic stenosis and other diseases need to be excluded.
- Note: The above arrhythmia must be clearly recorded, including course records, nursing records, electrocardiogram, Holter, bedside ECG monitoring, telemetry ECG monitoring, portable ECG recorder, implanted device with program control data, including ECG Event recorders, pacemakers,ICDs, etc.
- health checkers:physical examination patients without history of structural heart disease such as coronary heart disease or cardiomyopathy
- patients or health checkers can learn to use microelectrocardiograph device after simple technical training;
- patients or legal representatives or health checkers are willing and able to sign informed consent
Exclusion
- people who are pregnant or ready to become pregnant
- people who are unable or unwilling to follow the study protocol and complete follow-up
- people with uncontrolled hyperthyroidism and hypothyroidism, severe infection, severe hepatic and renal insufficiency (ALT≧3 times, or/and eGFR≦30mL/min calculated by any formula), malignancy, etc.
- people with all kinds of idiopathic ventricular tachycardia diagnosed by electrocardiogram or electrophysiological examination, including idiopathic ventricular tachycardia in special parts such as left posterior branch, left anterior branch, right ventricular outflow tract, left ventricular outflow tract, etc.
- people with various structural heart diseases, including various congenital heart diseases, rheumatic or senile heart valve disease
- people with acute or subacute infective endocarditis, acute viral myocarditis
- people with pulmonary arterial hypertension caused by right ventricular dysfunction alone, by UCG or right heart catheter examination PASP ≧ 40mmHg
- people with severe electrolyte imbalance, acid-base imbalance
- people with cardiac arrest caused by various severe bradyarrhythmias
- people with known allergic reactions to adhesives or hydrogels
- people whose skin cannot be pasted by electrode beacuse of a recent surgery.
- people who are participating in other clinical trials and may affect the data collection of this study
- people who have other situations that are not suitable for joining the group
- Exit criteria:
- people participating in the study can withdraw from the study at any time
- people ask researchers for their desire to terminate the study
- if the study jeopardizes the patient's health, the researcher can decide at any time to let the patient withdraw from the study.
Key Trial Info
Start Date :
April 10 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
2200 Patients enrolled
Trial Details
Trial ID
NCT03485079
Start Date
April 10 2018
End Date
December 31 2022
Last Update
April 2 2018
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China