Stress ECG Test for the Evaluation of the Risk of Sudden Cardiac Death in a Paediatric Cohort With WPW Pattern

Brief Title

Stress ECG Test for the Evaluation of the Risk of Sudden Cardiac Death in a Paediatric Cohort With WPW Pattern

Official Title

Reproducibility and Validity of the Stress ECG Test for the Evaluation of the Risk of Sudden Cardiac Death in a Paediatric Cohort With Preexcitation (WPW Pattern)

Brief Summary

      Patients with preexcitation are at risk for sudden cardiac death. The pathogenesis is a rapid
      antegrade conduction of atrial fibrillation over the accessory pathway to the ventricle
      resulting in ventricular fibrillation. Today it is possible to eliminate the conduction over
      the accessory pathway by catheter intervention (radiofrequency ablation) with a low rate of
      complications and a high rate of success. In clinical practice it is therefore important to
      estimate the risk for sudden cardiac death in an individual patient to give an advice to the
      patient and the parents about the further evaluation and therapeutic strategy. The velocity
      of the conduction over the accessory pathway can be estimated by analysing the ECG during
      sinus tachycardia. If the preexcitation disappears at a relatively low heart rate, the risk
      for sudden death is less than in patients with persisting preexcitation at the maximal heart
      rate. Compared to the gold standard i.e. measurement of the refractory period of the
      accessory pathway during invasive electrophysiological study (EPS), the measurements at the
      stress ECG have been reported to be a relatively poor indicator for an elevated risk which
      may be explained by a high intraindividual variability of this test. This study is designed
      to define the clinical relevance of the stress ECG in paediatric patients with preexcitation
      (compared to the invasive electrophysiological study).

      First Hypothesis:

      The results of the 3 stress ECG-tests are reproducible in an individual patient.

      Null hypothesis: there is no difference between the three measurements of cycle length during
      stress ECG. Alternate hypothesis: the difference between the three measurements of cycle
      length is > 10%.

      Second Hypothesis:

      There is a close correlation between the results at stress ECG and the results at the
      invasive electrophysiological Intervention.
    

Detailed Description

      Single centre, interventional study. There will be no randomisation or blinding.

      This study evaluates the stress ECG test as a non-invasive method of risk stratification in
      patients with WPW syndrome. For the non-invasive part a stress electrocardiogram on a
      treadmill is used. The invasive comparison is made with an electrophysiological study (EPS)
      in the catheterization laboratory. Nowadays the gold standard for measuring the antegrade
      effective refractory period of the accessory pathway is the invasive EPS.

      Study category A; there is only a minimal risk and a minimal burden to the study
      participants; The stress ECG test is a recommended test for this specific patient group as
      indicated in international guidelines.

      The responsible investigator at the single study site ensures that approval from an
      appropriately constituted Competent Ethics Committee (CEC), is sought for the clinical study.

      Objectives: 1) The study seeks primarily to evaluate the reproducibility of the loss of the
      preexcitation in repetitive stress ECG test in paediatric patients with WPW pattern in the
      view of an accurate estimation of the individual risk for sudden cardiac death.

      2) To compare the results of non-invasive ECG measurements with measurements taken during
      invasive EPS and clinical/anatomical parameters.

      Planned Analysis: Descriptive statistic is applied to all clinical parameters. All the 3
      cycle lengths out of the stress ECG are compared individually with the ERP-AP from the
      invasive EPS. If there is an average from the cycle length, this would be compared with the
      ERP-AP as well. And then we compare whether the difference between the cycle length and the
      ERP-AP is similar in a group of patients (high/low risk) or even in all patients.

      To demonstrate those results we use the Bland-Altman plot. There will also be a graph with
      the distribution of age of all patients. It will be interesting to see whether the age
      influences the results for example in relation to high or low risk.

      After the EPS, the patients are divided into 2 risk categories: high risk (ERP-AP ≤ 250 ms)
      and low risk (ERP-AP > 250ms) as measured at the EPS.

      At the end a risk factor analysis is made. All the parameters out of the case report form
      will be analysed whether the patient has high or low risk.
    


Study Type

Interventional


Primary Outcome

Cycle length (CL) at the Stress ECG Test

Secondary Outcome

 ERP-AP from invasive EPS

Condition

Wolff-Parkinson-White Syndrome

Intervention

Stress test (ECG)

Study Arms / Comparison Groups

 Stress ECG Test
Description:  The whole study cohort undergoes the same diagnostic workup including stress test (ECG)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

20

Start Date

April 13, 2017

Completion Date

March 2021

Primary Completion Date

February 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Informed Consent as documented by signature (Appendix Informed Consent Form)

          -  Preexcitation in resting ECG (WPW ECG Pattern)

          -  Age between 8 and 18 years

          -  Invasive EPS must be indicated/planned at the Children's Hospital Zurich

        Exclusion Criteria:

          -  Inability to follow the procedures of the study, e.g. due to language problems or
             psychological disorders of the participant

          -  Inability to walk/run on a treadmill
      

Gender

All

Ages

8 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Christian Balmer, PD Dr. med., , 

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT03207373

Organization ID

2016-01943


Responsible Party

Sponsor-Investigator

Study Sponsor

Christian Balmer


Study Sponsor

Christian Balmer, PD Dr. med., Principal Investigator, University Childrens Hospital


Verification Date

June 2020