Clinical trial NCT03590925: Evaluation of the Improvement of Primary Prevention in Ischemic Cardiomyopathy Patients Using New Screening and Referring System (Advance-ICM)
Official title: Evaluation of the Improvement of Primary Prevention in Ischemic Cardiomyopathy Patients Using New Screening and Referring System (Advance-ICM)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Cardiomyopathy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who undergo ICD implantation for the primary prevention of sudden cardiac death with severe LV dysfunction (ejection fraction ≤ 40%) by ICM.

Indications for ICD implantation for primary prevention in accordance with 2016 revised Korean indication guideline on ICD implantation

* FU LVEF ≤ 30% (at least 40 days post-myocardial infarction)
* FU LVEF 31\~35%, NYHA class II, III (at least 40 days post-myocardial infarction)
* FU LVEF ≤ 40%, NSVT (Holter), inducible VF or sustained VT at electrophysiological study (at least 40 days post-myocardial infarction)

Brief summary: The patients who undergo ICD(implantable cardioverter defibrillator) implantation for the primary prevention of sudden cardiac death with severe LV(left ventricle) dysfunction (ejection fraction ≤ 40%) by ICM(idiopathic cardiomyopathy).

Indications for ICD implantation for primary prevention in accordance with 2016 revised Korean indication guideline on ICD implantation

* FU LVEF(Left Ventricular Ejection Fraction) ≤ 30% (at least 40 days post-myocardial infarction)
* FU LVEF 31\~35%, NYHA(the New York Heart Association) class II, III (at least 40 days post-myocardial infarction)
* FU LVEF ≤ 40%, NSVT(non-sustained ventricular tachycardia) (Holter), inducible VF(ventricular flutter) or sustained VT(ventricular tachycardia) at electrophysiological study (at least 40 days post-myocardial infarction)


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Patients eligible for the indications for ICD implantation for primary prevention indication in accordance with 2016 revised Korean indication guideline on ICD implantation
* Patients should be managed by non-EP physician
* Patients who are willing to sign the informed consent
* Patients who are willing to receive the implantation and post-operative follow-up

Exclusion Criteria:

* Malignant tumor
* Life expectancy \< 12 months
* Patients unable or unwilling to cooperate in the study procedures

Primary outcomes:
measure: Improvement of the quality of care in patients with ICM
timeFrame: 3 years
Secondary outcomes:
measure: Improvement of the cardiovascular outcome of patients
timeFrame: 3 years
measure: Improvement of the cardiovascular outcome of patients
timeFrame: 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Study officials:
References:
citation: Lee JH, Yu HT, Oh IY, Choi EK, Sung JH, Lee YS, Kim JY, Baek Y, Park J, Joung B; ADVANCE-ICM investigators. Clinical and Hospital Factors Affecting Treatment with Primary Prevention Implantable Cardioverter-Defibrillators in Ischemic Cardiomyopathy Patients. Yonsei Med J. 2020 Nov;61(11):942-950. doi: 10.3349/ymj.2020.61.11.942.