Heart DiseaseMASTERSCREENNCT02923518
Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes)
An observational study of Heart Disease, run by LHL Helse at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Disease
- What is being tested?
- Questionnaire
- How many people
- 86 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2016to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- > 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
Who cannot join
- < 35 yrs old Known heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes) Who Participate in Long Distance Endurance Training and Competitions.
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.
Read the detailed 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.
- Conditions
- Heart Disease
- Being tested
- Questionnaire
- Keywords
- Heart Screening, Master Athletes, Cardiovascular Disease
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Observational study without any intervention described under intervention type
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire | |
| Control group | Those without a positive score on the two scores listed above. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- LHL Helse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hege Lundring, M.D., Study director, General manager the LHL-clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923518
- Sponsor's protocol ID
- 2016/21007
- Other IDs
- 2016
- Acronym
- MASTERSCREEN
- Status last verified
- Aug 2018
- First submitted
- 1 Oct 2016
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes) Who Participate in Long Distance Endurance Training and Competitions.
- ClinicalTrials.gov ID
- NCT02923518
- Acronym / sponsor ID
- MASTERSCREEN / 2016/21007
- Conditions
- Heart Disease
- Keywords
- Heart Screening, Master Athletes, Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- LHL HelseUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inclusion group | – | Other: QuestionnaireInclusion group: Those with a positive score in a questionnaire including symptoms and family history and/or high risk-score in the NORRISK-score system. |
| Control group | – | Other: QuestionnaireThose without a positive score on the two scores listed above. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- > 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
Key exclusion criteria (1 listed)
- < 35 yrs old Known heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireObservational study without any intervention described under intervention type | Other | Control group, Inclusion group |
Primary outcome
Differences among two groups of senior athletes in detecting heart diseases by a screening program
Time frame: One year
Examine if a simple screening program is efficient in detecting heart diseases
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hege Lundring, M.D. study director
General manager the LHL-clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease, run by LHL Helse at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences among two groups of senior athletes in detecting heart diseases by a screening program (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.