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出境医 / 临床实验 / PREVENTION-ACHD Risk Score (PREVENTIONACHD)

PREVENTION-ACHD Risk Score (PREVENTIONACHD)

Study Description
Brief Summary:

Sudden cardiac death (SCD) is one of the major causes of mortality in adults with congenital heart disease (ACHD). Risk stratification for sudden cardiac death in this patient group is challenging and at the current moment there are no clear guidelines on implantable cardioverter-defibrillator (ICD) implantation for primary prevention of SCD in this young patient population. The reason for this is the fact that this is a heterogenous group of patients and SCD is a relatively rare event. Because of this there have been no prospective studies on SCD in ACHD. However, multiple retrospective studies on ICD implantation in ACHD have shown that this treatment does appear to be effective. Researchers from the Academic Medical Center have identified several risk factors for sudden cardiac death. A risk score was created using this data, which has been validated in an internal and external cohort in a retrospective setting. The design of this study, including the conception of the risk score, its calculation method and validation will be published in an international scientific peer-reviewed journal.

The hypothesis of this study is that the risk score accurately predicts the risk of sudden cardiac death.


Condition or disease Intervention/treatment
Death, Sudden, Cardiac Ventricular Fibrillation Ventricular Tachycardia Congenital Heart Disease Diagnostic Test: PREVENTION-ACHD risk score

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 783 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: PRospEctiVE Study on implaNTable cardIOverter Defibrillator Therapy and SuddeN Cardiac Death in Adults With Congenital Heart Defects
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : June 30, 2018
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia [ Time Frame: 2 years ]
    The rate of sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia in adult congenital heart disease patients


Secondary Outcome Measures :
  1. Sudden cardiac death [ Time Frame: 2 years ]
    The rate of sudden cardiac death in adult congenital heart disease patients


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 19, 2019
First Posted Date May 21, 2019
Last Update Posted Date May 21, 2019
Actual Study Start Date January 1, 2015
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 19, 2019) 		Sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia [ Time Frame: 2 years ]
The rate of sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia in adult congenital heart disease patients
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 19, 2019) 		Sudden cardiac death [ Time Frame: 2 years ]
The rate of sudden cardiac death in adult congenital heart disease patients
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PREVENTION-ACHD Risk Score
Official Title PRospEctiVE Study on implaNTable cardIOverter Defibrillator Therapy and SuddeN Cardiac Death in Adults With Congenital Heart Defects
Brief Summary

Sudden cardiac death (SCD) is one of the major causes of mortality in adults with congenital heart disease (ACHD). Risk stratification for sudden cardiac death in this patient group is challenging and at the current moment there are no clear guidelines on implantable cardioverter-defibrillator (ICD) implantation for primary prevention of SCD in this young patient population. The reason for this is the fact that this is a heterogenous group of patients and SCD is a relatively rare event. Because of this there have been no prospective studies on SCD in ACHD. However, multiple retrospective studies on ICD implantation in ACHD have shown that this treatment does appear to be effective. Researchers from the Academic Medical Center have identified several risk factors for sudden cardiac death. A risk score was created using this data, which has been validated in an internal and external cohort in a retrospective setting. The design of this study, including the conception of the risk score, its calculation method and validation will be published in an international scientific peer-reviewed journal.

The hypothesis of this study is that the risk score accurately predicts the risk of sudden cardiac death.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients with congenital heart disease with a diagnosis of one of the congenital heart defects displayed in the risk score model.
Condition
  • Death, Sudden, Cardiac
  • Ventricular Fibrillation
  • Ventricular Tachycardia
  • Congenital Heart Disease
Intervention Diagnostic Test: PREVENTION-ACHD risk score
The predicted risk of sudden cardiac death according to a risk score will be tested by the actual rate of sudden cardiac death
Study Groups/Cohorts Not Provided
Publications * Vehmeijer JT, Koyak Z, Zwinderman AH, Harris L, Peinado R, Oechslin EN, Silversides CK, Bouma BJ, Budts W, van Gelder IC, Oliver JM, Mulder BJM, de Groot JR. PREVENTION-ACHD: PRospEctiVE study on implaNTable cardioverter-defibrillator therapy and suddeN cardiac death in Adults with Congenital Heart Disease; Rationale and Design. Neth Heart J. 2019 Oct;27(10):474-479. doi: 10.1007/s12471-019-1297-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 19, 2019) 		783
Original Actual Enrollment Same as current
Actual Study Completion Date June 30, 2018
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • adult (≥18 years old) patient with a diagnosis of a congenital heart defect.

Exclusion Criteria:

  • Patients of whom follow up is not possible, e.g. no permanent home address, living outside of or expecting to move out of the area wherein travelling to the investigating hospital outpatient clinic is possible.

    • Patients with documented sustained ventricular tachycardia or ventricular fibrillation.
    • Patients for whom the risk is not calculable because of a congenital heart disease diagnose not represented in the risk score.
    • Patients for whom the risk score is not calculable because of missing data
    • Patients with recent (<3 months ago) myocardial infarction.
    • Patients in whom the high SCD-risk status depends on an impaired ejection fraction that is expected to improve, e.g. due to tachycardiomyopathy.
    • Patients with a guideline defined contraindication for ICD implantation.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03957824
Other Study ID Numbers 2014_248#C20141535
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Joris R. de Groot, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators Not Provided
Investigators
Principal Investigator: Joris R de Groot, MD, PhD Academic Medical Center - University of Amsterdam (AMC-UvA)
PRS Account Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date May 2019

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