NCT03370679

Brief Summary

With this project the investigators aim to investigate whether premature ventricular complexes (PVC) have a prognostic significance in persons without structural heart disease. Further the investigators look at the possible connection between PVC-morphology and clinical outcome and investigate whether advanced cardiac imaging-methods may identify subtle signs of heart disease in PVC-patients with normal findings at echocardiography.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2017

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

4.3 years

First QC Date

November 30, 2017

Last Update Submit

February 1, 2018

Conditions

Premature Ventricular Complexes MultiplePremature Ventricular Contraction

Keywords

PrematureVentricularComplexesBeatsPrognosis

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality compared with sex and age-matched control population. Data for Control population obtained via Socialstyrelsen (The Swedish Health Board)

    Average follow-up time 3,5 years

Secondary Outcomes (1)

  • Cardiovascular morbidity

    Average follow-up time 3,5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Premature Ventricular Complexes treated at Three major hospitals in the Stockholm area (Danderyd Hospital, Karolinska Hospital and Södersjukhuset Hospital)

You may qualify if:

  • \- Diagnosed with Premature Ventricular Complexes at Three major Hospitals in Stockholm, Sweden

You may not qualify if:

  • History of Myocardial Infarction
  • Undergone coronary arterty bypass grafting (CABG)
  • Finding of Heart Failure at echocardiography
  • Direct or indirect findings of coronary ischaemia at exercise test, coronary angiography or other equivalent examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hjärtkliniken Danderyds Sjukhus

Stockholm, Sweden

Location

MeSH Terms

Conditions

Ventricular Premature ComplexesPremature Birth

Condition Hierarchy (Ancestors)

Cardiac Complexes, PrematureArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Raffaele Scorza, MD

    Karolinska Institutet - Danderyd Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 12, 2017

Study Start

September 1, 2013

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

SE(1)