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

NCT ID: NCT03370679

Last Updated: 2018-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Premature Ventricular Complexes Multiple Premature Ventricular Contraction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danderyd Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raffaele Scorza, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet - Danderyd Hospital

Locations

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HjÀrtkliniken Danderyds Sjukhus

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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PULSE

Identifier Type: -

Identifier Source: org_study_id

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