Risk Assessment in Patients With Symptomatic- and Asymptomatic Preexcitation

Brief Title

Risk Assessment in Patients With Symptomatic- and Asymptomatic Preexcitation

Official Title

Risk Assessment in Patients With Symptomatic- and Asymptomatic Preexcitation

Brief Summary

      Prospective cohort study including 150 patients with pre-excitation on ECG referred to our
      clinic for risk assessment. There will be equal numbers of symptomatic and asymptomatic
      patients included in the study. Each patient will perform an exercise stress test on bicycle
      before an invasive electrophysiological test. The purpose of this study is to compare
      exercise stress testing on bicycle to an invasive electrophysiological study, regarding risk
      assessment of patients with pre-excitation. The electrophysiology study is set as reference.
    

Detailed Description

      Hypothesis:

      The sensitivity and specificity for exercise stress test (bicycle) is low in identifying
      patients with benign accessory pathways and cannot replace an invasive electrophysiological
      study in risk assessment of symptomatic and asymptomatic patients with pre-excitation.
      Invasive electrophysiological assessment should be recommended for all patients with
      pre-excitation despite symptoms or documented arrhythmia.

      Methods:

      Prospective cohort study including 150 patients with pre-excitation on ECG referred to our
      clinic for risk assessment. There will be equal numbers of symptomatic and asymptomatic
      patients included in the study. Each patient will perform an exercise stress test on bicycle
      before an invasive electrophysiological test. The purpose of this study is to compare
      exercise stress testing on bicycle to an invasive electrophysiological study, regarding risk
      assessment of patients with pre-excitation. The electrophysiology study is set as reference.

      A. Instruments and methods for analysis:

        -  All patients will perform an exercise stress test on a test bike according to standard
           protocol. ECG will be monitored closely regarding loss of pre-excitation during
           exercise.

        -  After exercise testing all patients will undergo an invasive electrophysiological study
           according to standard protocol.

      This procedure is set as reference in identifying potentially dangerous accessory pathways.

        -  APERP as well as shortest R-R interval during atrial fibrillation, when applicable, will
           be used to characterize the conduction properties of the pathway defining high risk
           pathway with APERP ≤ 250 ms with or without isoprenaline.

        -  Inducibility in AVRT (orthodromic or antidromic reentry tachycardia) and atrial
           fibrillation will be recorded as well as tachycardia cycle length.

        -  The results of the two tests will be compared with each patient being their own control.

      Programmed stimulation for risk assessment in patients with pre-excitation/accessory
      pathways:

        1. AV block or block in AP during IAP, ms

        2. VA block or block in AP during IVP, ms

        3. Antegrade curve (single ES 600 ms or longer and 400 ms): APERP And AVNERP

        4. Retrograde curve (single ES 600 ms): Retrograde APERP and AVNERP

        5. Tachycardia induction (Double ES from atrium): Inducibility

        6. Burst pacing from atrium

        7. Isoprenaline: Dose adjustment until heart rate>100/min or >50% increase from basal
           level.

             -  Antegrade curve during isoprenaline: APERP, AVNERP

             -  Retrograde curve during Isoprenaline:

      Retrograde APERP and AVNERP

      - Tachycardia induction during Isoprenaline

      Statistical analysis: Sensitivity, specificity, positive predictive value and negative
      predictive value of exercise stress test will be assessed, using the electrophysiological
      study as a reference standard. A true positive and a false negative will be defined,
      respectively, as the persistence and the disappearance of pre-excitation in the symptomatic
      and asymptomatic group. A true negative and a false positive will be defined, respectively,
      as the disappearance and the persistence of pre-excitation in the symptomatic and
      asymptomatic group. Moreover, we will consider the shortest value between the minimum RR
      interval during atrial fibrillation and accessory pathway anterograde effective refractory
      period (APERP) in each patient and look for the value that could be predicted by noninvasive
      tests with the best combination of sensitivity, specificity, positive and negative predictive
      value.

      Chi Square statistics will be used in comparing categorical data such as inducibility and
      tachycardia cycle length.

      B. Calculation of power: With the planned number of patients, 150, a 10% difference should be
      detected with a power of 80% at α 0,1.

      C. Expected results: We expect exercise testing to have high sensitivity, but low specificity
      and a low positive predictive value.
    


Study Type

Observational


Primary Outcome

RASAP


Condition

Wolff-Parkinson-White Syndrome

Intervention

Electrophysiology testing and exercise stress testing


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

Procedure

Estimated Enrollment

150

Start Date

December 1, 2016

Completion Date

December 1, 2020

Primary Completion Date

December 1, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Ventricular pre exciatation on 12 lead ECG

        Exclusion Criteria:

          -  Inability to perform invasive electrophysiology testing or exercise stress test on
             bicycle.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Mats Jensen-Urstad, Professor, +46706301006, [email protected]

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT03301935

Organization ID

RASAP


Responsible Party

Principal Investigator

Study Sponsor

Karolinska University Hospital


Study Sponsor

Mats Jensen-Urstad, Professor, Principal Investigator, Karolinska Institutet


Verification Date

February 2020