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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02923518
Other study ID # 2016/21007
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2016
Est. completion date November 2017

Study information

Verified date August 2018
Source LHL Helse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Forty senior athletes between 35 to approximately 80 yrs old with a positive score will be included in one group, and another forty seniors without positive score in a control group. Each of them will be tested with an cardiorespiratory exercise test (CPET) with ECG and examined with echocardiography together with an usual medical examination and blood tests (cholesterol and HbA1c-glucose). Some with symptoms of arrhythmias will be examined by 24-hours Holter-monitoring.

The main purpose of the study is to assess if men and women with a positive score on the questionnaire og NORRISK-screening (risk calculator for coronary heart disease) have more detectable heart diseases than the control group.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 85 Years
Eligibility Inclusion Criteria:

> 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

Exclusion Criteria:

< 35 yrs old Known heart disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
Observational study without any intervention described under intervention type

Locations

Country Name City State
Norway LHL-clinics Feiring Feiring

Sponsors (1)

Lead Sponsor Collaborator
LHL Helse

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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