NCT03205098

Brief Summary

To assess the evolution of biological markers of mesenteric ischemia during ultratrail.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2015

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

11 days

First QC Date

June 21, 2017

Last Update Submit

June 29, 2017

Conditions

Ultra-trail Participation

Keywords

biological markersmesenteric ischemiaultratrail

Outcome Measures

Primary Outcomes (1)

  • Assess biological markers of mesenteric ischemia (IFABP)

    during ultratrail.

    at day 1

Secondary Outcomes (1)

  • Relationship between digestive symptoms and biological markers (IFABP).

    at day 1

Study Arms (1)

Runners

To assess the evolution of biological markers of mesenteric ischemia during ultratrail.

Biological: Blood analysis

Interventions

Blood analysisBIOLOGICAL

Blood test of biological markers of mesenteric ischemia

Runners

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

participants or populations are selected based on predefined criteria

You may qualify if:

  • Healthy Voluntary Subject
  • Age \> 18 years
  • Written consent
  • Subject affiliated to Social Security
  • Medical certificate (mandatory to take part in the ultra-trail)

You may not qualify if:

  • Refusal to participate
  • Subject with legal protection (guardianship, trusteeship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

MeSH Terms

Conditions

Mesenteric Ischemia

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPeritoneal DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Sébastien PERBET

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2017

First Posted

July 2, 2017

Study Start

June 19, 2015

Primary Completion

June 30, 2015

Study Completion

September 30, 2016

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

FR(1)