ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study of Myocardial Effects Following an Endurance Race

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03549364
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Fredrik H Nystrom, University Hospital, Linkoeping

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.


Condition or disease Intervention/treatment Phase
Myocardial Blood Flow Behavioral: Endurance Race Not Applicable

Detailed 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".


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of the Myocardial Effects of an Endurance Race as Evaluated by Computer Tomography
Actual Study Start Date : May 24, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Arm Intervention/treatment
Experimental: 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
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




Primary Outcome Measures :
  1. Change in myocardial blood flow by the race? [ Time Frame: All investigations are performed < 2 months ]
    Detection of potential differences in blood flow between occasion 1 and 2 and 3



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy subjects, experienced in long distance running

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549364


Contacts
Contact: Fredrik H Nyström, MD PhD Professor 0736569303 ext +46 fredrik.h.nystrom@gmail.com

Locations
Sweden
University Hospital of Linkoping Recruiting
Linkoping, Sweden, 58185
Contact: Fredrik H Nystrom, MD, prof.         
Contact    +46736569303    fredrik.h.nystrom@gmail.com   
Principal Investigator: Fredrik H Nystrom, MD PhD prof         
Sponsors and Collaborators
University Hospital, Linkoeping

Responsible Party: Fredrik H Nystrom, MD PhD professor head of internal medicine, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT03549364     History of Changes
Other Study ID Numbers: 2017/429-31
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No