Pilot Study of Myocardial Effects Following an Endurance Race

Myocardial Blood Flow Clinical Trial

Official title:

A Pilot Study of the Myocardial Effects of an Endurance Race as Evaluated by Computer Tomography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03549364
• Other study ID #: 2017/429-31
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2019
• Source: University Hospital, Linkoeping
• Contact: Fredrik H Nyström, MD PhD Professor
• Phone: 0736569303
• Email: fredrik.h.nystrom[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Healthy subjects, experienced in long distance running

Exclusion Criteria:

Significant renal, kidney, heart, liver or musculoskeletal disease.

Related Conditions & MeSH terms

• Myocardial Blood Flow

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Sweden	University Hospital of Linkoping	Linkoping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in myocardial blood flow by the race?	Detection of potential differences in blood flow between occasion 1 and 2 and 3	All investigations are performed < 2 months