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

July 16, 2018 updated by: Yonsei University

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)

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
        • Contact:
          • Boyoung Joung, MD, Ph.D
          • Phone Number: 82-2-2228-8460
          • Email: cby6908@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of the quality of care in patients with ICM
Time Frame: 3 years
the rate of device therapy(ICD or CRT-D(Cardiac Resynchronization Therapy-Device))
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2018

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

June 19, 2018

First Submitted That Met QC Criteria

July 16, 2018

First Posted (Actual)

July 18, 2018

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2018-0075

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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