NCT03549364

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

May 24, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

May 11, 2018

Last Update Submit

April 23, 2019

Conditions

Myocardial Blood Flow

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Endurance race

EXPERIMENTAL

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

Behavioral: Endurance Race

Interventions

Endurance RaceBEHAVIORAL

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

Endurance race

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects, experienced in long distance running

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Linkoping

Linköping, 58185, Sweden

RECRUITING

Central Study Contacts

Fredrik H Nyström, MD PhD Professor

CONTACT

0736569303fredrik.h.nystrom@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD professor head of internal medicine

Study Record Dates

First Submitted

May 11, 2018

First Posted

June 8, 2018

Study Start

May 24, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 24, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)