The Prognostic Significance of Premature Ventricular Complexes in Patients Without Structural Heart Disease (PULSE)

February 1, 2018 updated by: Danderyd Hospital
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.

Study Overview

Status

Completed

Conditions

Detailed Description

The PULSE project consists of four different studies:

  • in study one the investigators include patients who are evaluated because of PVCs and have no signs of structural heart disease at echocardiography and exercise test. The investigators follow them (average follow-up time 3,5 years) to investigate if they have a higher mortality och cardiovascular morbidity than standard population
  • in study two the investigators carry out a sub-group analysis of the population in study one to assess whether PVC:s different sites of origin (morphology) are related to the clinical outcome
  • in study three the investigators include persons with a high PVC-burden (at least 10 000 PVC:s/day) and normal echocardiography. The included subjects undergo magnetic resonance (MR) to investigate whether it can identify signs of heart disease where standard echocardiography cannot

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Hjärtkliniken Danderyds Sjukhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Average follow-up time 3,5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular morbidity
Time Frame: Average follow-up time 3,5 years
Incidence of heart failure and myocardial infarction in the study population compared with age and sex-matched Controls. Control data obtained via Socialstyrelsen (The Swedish Health Board)
Average follow-up time 3,5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danderyd Hospital

Investigators

  • Principal Investigator: Raffaele Scorza, MD, Karolinska Institutet - Danderyd Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

November 30, 2017

First Submitted That Met QC Criteria

December 6, 2017

First Posted (Actual)

December 12, 2017

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PULSE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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