Evaluation of the Improvement of Primary Prevention in Is... | NCT03590925

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

NCT03590925

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Jul 18, 2018Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Ischemic Cardiomyopathy

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 21, 2018Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Jun 19, 2018

First Submission Date that Met QC Criteria

Jul 16, 2018

First Posted Date

Jul 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2018

Last Update Posted Date

Jul 18, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
new screening and referring system of ICD		Non-randomized, non-blinded, multi-center study receiving new screening and referring system of ICD

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Improvement of the cardiovascular outcome of patients	Cardiovascular outcome (cardiovascular death, Non-cardiovascular death)	3 years
Improvement of the cardiovascular outcome of patients	Pattern of arrhythmia measured by EKG or echocardiography

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine	Recruiting	Seoul		03722	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33107237	Derived	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.