Pilot Study of Myocardial Effects Following an Endurance Race

NCT ID: NCT03549364

Last Updated: 2019-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-24

Study Completion Date

2019-12-31

Brief Summary

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Ten healthy subjects perform a baseline computer tomography (CT) of the heart and routine laboratory blood tests for myocardial injury and inflammation.

The same data are collected \<24 hours after an endurance race corresponding to a maraton run (i.e. about 40 km of running and/or about 2.5 hours hard training or more). A third collection of lab tests and CT is done a couple of weeks after the race. Magnetic resonance imaging is also performed in parallell to the CT on occasions 2 and 3 in most subjects, serving as a reference for determination of myocardial blood flow.

Detailed Description

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Ten healthy subjects perform a baseline computer tomography (CT) of the heart and routine laboratory blood tests (troponin T, hs-CRP, CK-mb etc) for myocardial injury and inflammation.

The same data are collected \<24 hours after an endurance race corresponding to a maraton run (i.e. about 40 km of running and/or about 2.5 hours hard training or more). A third collection of lab tests and CT is done a couple of weeks after the race. Magnetic resonance imaging (MRI) is also performed in parallell to the CT on occasions 2 and 3 in most subjects, serving as a reference for determination of myocardial blood flow. The CT of the heart includes contrast injection and blood flow will be determined by a recently developed based on very powerful computers using "machine learning".

Conditions

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Myocardial Blood Flow

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Endurance race

1. baseline investigations with CT and lab tests
2. the same CT and lab tests \< 24h after an endurance race
3. CT and lab tests again about 1-2weeks after the race

Group Type EXPERIMENTAL

Endurance Race

Intervention Type BEHAVIORAL

1 CT and lab tests, 2 CT and lab tests within 24h of a race, 3 follow up investigations 1-2 weeks after the race with CT and lab tests

Interventions

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Endurance Race

1 CT and lab tests, 2 CT and lab tests within 24h of a race, 3 follow up investigations 1-2 weeks after the race with CT and lab tests

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Healthy subjects, experienced in long distance running

Exclusion Criteria

Significant renal, kidney, heart, liver or musculoskeletal disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Fredrik H Nystrom

MD PhD professor head of internal medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Linkoping

Linköping, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Fredrik H Nyström, MD PhD Professor

Role: CONTACT

0736569303 ext. +46

Facility Contacts

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Fredrik H Nystrom, MD, prof.

Role: primary

Role: backup

+46736569303

Other Identifiers

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2017/429-31

Identifier Type: -

Identifier Source: org_study_id

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