Risk Assessment in Patients With Symptomatic- and Asymptomatic Preexcitation

NCT03301935 | Completed

• 1 other identifier: RASAP
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Wolff-Parkinson-White Syndrome

Keywords

Risk assessment

Outcome Measures

Primary Outcomes (1)

• RASAP

  Number of potentially dangerous pathways (i.e APERP \<250 ms) identified by exercise stress test compared to the invasive electrophysiological test in the symptomatic- and asymptomatic Group.

  Approximately 1 year from inclusion to 6 months follow-up.

Interventions

Electrophysiology testing and exercise stress testing PROCEDURE

Each patient will perform an exercise stress test on bicycle before an invasive electrophysiological test. Both examinations will be performed according to current Clinical practice.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with documented ventricular preexcitation, referred for risk assessment to the Arrhythmia department at Karolinska University Hospital, were asked to participate in the study.

You may qualify if:

• Ventricular pre exciatation on 12 lead ECG

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, SE-14186, Sweden

Location

Related Publications (1)

• Jemtren A, Saygi S, Akerstrom F, Asaad F, Bourke T, Braunschweig F, Carnlof C, Drca N, Insulander P, Kenneback G, Nordin AP, Sadigh B, Rickenlund A, Saluveer O, Schwieler J, Svennberg E, Tapanainen J, Turkmen Y, Bastani H, Jensen-Urstad M. Risk assessment in patients with symptomatic and asymptomatic pre-excitation. Europace. 2024 Feb 1;26(2):euae036. doi: 10.1093/europace/euae036.

  PMID: 38363996 DERIVED

MeSH Terms

Conditions

Wolff-Parkinson-White Syndrome

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Pre-Excitation Syndromes; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Mats Jensen-Urstad, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: October 4, 2017
• Study Start: December 1, 2016
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)