NCT02923518

Brief Summary

In 2010 there was published new European recommendations for assessment of adult and elderly men and women, who want to start with physical activity and/or participate in endurance contests. In this study we want to test if a group of people with positive score on a self-reported questionnaire and/or high-risk score in a risk scoring system (NORRISK) have more undetected heart diseases than a control group with no reported or detected risk factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

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

First Submitted

Initial submission to the registry

October 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

October 1, 2016

Last Update Submit

August 29, 2018

Conditions

Keywords

Heart ScreeningMaster AthletesCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Differences among two groups of senior athletes in detecting heart diseases by a screening program

    Examine if a simple screening program is efficient in detecting heart diseases

    One year

Study Arms (2)

Inclusion group

Inclusion group: Those with a positive score in a questionnaire including symptoms and family history and/or high risk-score in the NORRISK-score system.

Other: Questionnaire

Control group

Those without a positive score on the two scores listed above.

Other: Questionnaire

Interventions

Observational study without any intervention described under intervention type

Control groupInclusion group

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Senior men and women \< 35 yrs participating in long-enurance competitions. 40 persons in a group with positive score and one group without.

You may qualify if:

  • \> 35 yrs old Master athletes Positive score on symptom based questionnaire or high risk score No known heart disease Participated in long-term endurance competitions

You may not qualify if:

  • \< 35 yrs old Known heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LHL-clinics Feiring

Feiring, 2093, Norway

Location

MeSH Terms

Conditions

Heart DiseasesCardiovascular Diseases

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Hege Lundring, M.D.

    General manager the LHL-clinics

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 1, 2016

First Posted

October 4, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations