PREVENTION-ACHD Risk Score

NCT03957824 | Completed

• 1 other identifier: 2014_248#C20141535
• Study Type: observational
• Target: 783
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Death, Sudden, Cardiac; Ventricular Fibrillation; Ventricular Tachycardia; Congenital Heart Disease

Keywords

Risk score; Risk prediction; Prevention

Outcome Measures

Primary Outcomes (1)

• Sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia

  The rate of sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia in adult congenital heart disease patients

  2 years

Secondary Outcomes (1)

• Sudden cardiac death

  2 years

Interventions

PREVENTION-ACHD risk score DIAGNOSTIC_TEST

The predicted risk of sudden cardiac death according to a risk score will be tested by the actual rate of sudden cardiac death

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Related Publications (1)

• 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.

  PMID: 31270738 DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac; Ventricular Fibrillation; Tachycardia, Ventricular; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Tachycardia; Cardiac Conduction System Disease; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Joris R de Groot, MD, PhD

  Academic Medical Center - University of Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiac Electrophysiology and Atrial Fibrillation

Study Record Dates

• First Submitted: May 19, 2019
• First Posted: May 21, 2019
• Study Start: January 1, 2015
• Primary Completion: December 31, 2015
• Study Completion: June 30, 2018
• Last Updated: May 21, 2019

Record last verified: 2019-05