MASTERSCREEN: Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes)

• Sponsor: LHL Helse (Other)
• Overall Status: Completed
• CT.gov ID: NCT02923518
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Disease	Other: Questionnaire

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

• Study Type: Observational
• Actual Enrollment: 86 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes) Who Participate in Long Distance Endurance Training and Competitions.
• Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Nov 1, 2017
• Actual Study Completion Date: Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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; Observational study without any intervention described under intervention type
Control group Those without a positive score on the two scores listed above.	Other: Questionnaire; Observational study without any intervention described under intervention type

Outcome Measures

Primary Outcome Measures

1. Differences among two groups of senior athletes in detecting heart diseases by a screening program [One year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LHL-clinics Feiring	Feiring		Norway	2093

Sponsors and Collaborators

• LHL Helse

Investigators

• Study Director: Hege Lundring, M.D., General manager the LHL-clinics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LHL Helse
• ClinicalTrials.gov Identifier: NCT02923518
• Other Study ID Numbers: 2016/21007
• First Posted: Oct 4, 2016
• Last Update Posted: Aug 31, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by LHL Helse: Heart Screening; Master Athletes; Cardiovascular Disease
• Additional relevant MeSH terms: Heart Diseases

Study Results

No Results Posted as of Aug 31, 2018