## Protocol Section
### Identification Module
**NCT ID:** NCT03370679

**Acronym:** PULSE

**Brief Title:** The Prognostic Significance of Premature Ventricular Complexes in Patients Without Structural Heart Disease

**Official Title:** The Prognostic Significance of Premature Ventricular Complexes in Patients Without Structural Heart Disease

#### Organization Study ID Info
**ID:** PULSE
#### Organization
**Class:** OTHER
**Full Name:** Danderyd Hospital
### Status Module
#### Completion Date
**Date:** 2018-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-02-05

**Type:** ACTUAL

**Last Update Submit Date:** 2018-02-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-12

**Type:** ACTUAL

#### Start Date
**Date:** 2013-09

**Type:** ACTUAL

**Status Verified Date:** 2018-02

#### Study First Post Date
**Date:** 2017-12-12
**Type:** ACTUAL
**Study First Submit Date:** 2017-11-30
**Study First Submit QC Date:** 2017-12-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Danderyd Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**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

### Conditions Module

**Conditions:**

- Premature Ventricular Complexes Multiple

- Premature Ventricular Contraction

**Keywords:**

- Premature

- Ventricular

- Complexes

- Beats

- Prognosis

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1000

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Mortality

**Time Frame:** Average follow-up time 3,5 years

#### Secondary Outcomes

**Description:** 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)

**Measure:** Cardiovascular morbidity

**Time Frame:** Average follow-up time 3,5 years

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Stockholm

**Country:** Sweden

**Facility:** Hjärtkliniken Danderyds Sjukhus

#### Overall Officials

**Official 1:**

**Affiliation:** Karolinska Institutet - Danderyd Hospital

**Name:** Raffaele Scorza, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000007752

- Term: Obstetric Labor, Premature

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005117

- Term: Cardiac Complexes, Premature

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000075224

- Term: Cardiac Conduction System Disease

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M25869

- Name: Premature Birth

- Relevance: HIGH

- As Found: Premature

- ID: M9419

- Name: Heart Diseases

- Relevance: HIGH

- As Found: Heart Disease

- ID: M20921

- Name: Ventricular Premature Complexes

- Relevance: HIGH

- As Found: Premature Ventricular Complex

- ID: M10772

- Name: Obstetric Labor, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8260

- Name: Cardiac Complexes, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M1472

- Name: Cardiac Conduction System Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000047928

- Term: Premature Birth

- ID: D000006331

- Term: Heart Diseases

- ID: D000018879

- Term: Ventricular Premature Complexes

### Misc Info Module

- Version Holder: 2024-05-24
