Evaluation of the Improvement of Primary Prevention in Ischemic Cardiomyopathy Patients Using New Screening and Referring System (Advance-ICM)

NCT03590925 | Unknown

• 1 other identifier: 4-2018-0075
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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)

Conditions

Ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Improvement of the quality of care in patients with ICM

  the rate of device therapy(ICD or CRT-D(Cardiac Resynchronization Therapy-Device))

  3 years

Secondary Outcomes (2)

• Improvement of the cardiovascular outcome of patients

  3 years

• Improvement of the cardiovascular outcome of patients

  3 years

Study Arms (1)

new screening and referring system of ICD

Non-randomized, non-blinded, multi-center study receiving new screening and referring system of ICD

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 33107237 DERIVED

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 18, 2018
• Study Start: March 21, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 18, 2018

Record last verified: 2018-06

Locations

KR (1)