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

Ischemic Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03590925
• Other study ID #: 4-2018-0075
• Status: Recruiting
• Start date: March 21, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemia
• Ischemic Cardiomyopathy

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement of the cardiovascular outcome of patients	Cardiovascular outcome (cardiovascular death, Non-cardiovascular death)	3 years
Secondary	Improvement of the cardiovascular outcome of patients	Pattern of arrhythmia measured by EKG or echocardiography	3 years