NCT03601481

Brief Summary

Validation of a telemedicine software application for an automated treatment of cardio-vascular MRI completely identical for both CHUs. Providing the software application to other CHU seeking a tool suitable for multi-centric studies.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

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

March 3, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2014

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2020

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

Same day

First QC Date

July 17, 2018

Last Update Submit

September 5, 2024

Conditions

Myocardial Infarction

Keywords

telemedicinecardiac images

Outcome Measures

Primary Outcomes (9)

  • Precision of the localisation of endocardic and epicardic edge

    Validation of a software telemedecine for automatic treatment of cardio-vascular MRI

    Day 2

  • Volume of myocardic cavity

    Day 2

  • Ejection fraction

    Day 2

  • Weight of the myocard

    Day 2

  • Thickness of the myocard

    Day 2

  • Precision of the localisation of endocardic and epicardic edge

    6 months

  • Volume of myocardic cavity

    6 months

  • Weight of the myocard

    6 months

  • Thickness of the myocard

    6 months

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Major patient with heart attack

You may qualify if:

  • Age between 18 years and 75 yeras
  • heart attack with medical treatment within 12 hours
  • heart attack with or without segment S-T gap

You may not qualify if:

  • cardiogenic choc
  • medical history with heart attack,
  • medical history with left ventricle dysfonction (ejection fraction\< 45%),
  • medical history with clinic manifestations of heart failure,
  • medical history with surgical coronary revascularisation in the last 6 months,
  • congenital cardiopathy, myocardiopathy,
  • evolutive infection syndrome (HIV, VHB, VHC),
  • chronic inflammatory pathology,
  • leucopenia, thrombopenia, anemia,
  • medical history with treatment by G-CSF; EPO; GM-CSF,
  • stasis trouble, evolutive hemorragic syndrome, transfusion,
  • renal insuffisance (clearance MDRD \< 60ml/min),
  • renal insuffisance with creatinin \> 120 µmol/L,
  • hepatic insuffisance,
  • medical history of cancer or pathology with life expectancy \< 1 year,
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

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

Study Record Dates

First Submitted

July 17, 2018

First Posted

July 26, 2018

Study Start

March 3, 2014

Primary Completion

March 3, 2014

Study Completion

June 3, 2020

Last Updated

September 19, 2024

Record last verified: 2024-09