Evaluation of Infarct Size With 3D Rotational Angiography (EVATIAR)

January 26, 2018 updated by: Hospices Civils de Lyon
The size of the infarct is particularly important prognostic marker. It is clearly established that the extent of the infarct is not only correlated to mortality, but also long-term adverse events. The evaluation of the infarct size at the acute phase of the disease is therefore an essential clinical tool to adapt the immediate treatment and follow-up of patients. It is therefore crucial to have techniques that are effective, precise, reproducible, and easily performed during the acute phase to quantify the size of the infarct following angioplasty. Myocardial scintigraphy and cardiac MRI have been the standard examinations for the evaluation of infarct size. However, these exams are difficult to perform during the acute phase of the infarct owing to difficulties in monitoring unstable patients and the limited availability of the apparatus. It is for this reason that the investigators would like to investigate the rotational angiography (RA), which is comparable to a scanner in its mode of action but does not require transfer of patients as performed using the same apparatus that used for diagnostic coronarography and therapeutic angioplasty. RA is a radiological technique that uses the system employed for coronagraph, and consists rotating the fixed C-Arm around the patient and acquisition of a series of images that are then reconstituted. The investigators propose to evaluate the size of the infarct using RA in comparison with cardiac MRI (standard examination) performed as soon as possible after RA and the investigators hope to demonstrated that RA allows the measurement of an infarct as precisely as cardiac MRI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Hôpital Louis Pradel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admitted for myocardial infarction and fulfilling the following criteria:

    • Transitory or persistent ST elevation
    • Coronary occlusion (TIMI 0) treated by angioplasty or thrombotic acute stenosis treated or not by angioplasty
  • Planned coronarography
  • With social security coverage
  • Not under any legal protection;
  • The consent form signed.

Exclusion Criteria:

  • Patient unconscious or confused;

  • Presenting:

    • cardiogenic shock;
    • or signs of cardiac insufficiency;
    • or sustained cardiac arrhythmia;
    • or atrial fibrillation;
    • or sustained extrasystole;
    • or high degree block;
  • Contraindication for MRI;
  • Known history of hypersensitivity to MRI contrast agent;
  • Risk of pregnancy or proven pregnancy based on interview data;
  • Breast feeding;
  • Patient subject to legal guardianship by a court;
  • Incapacity to express consent;
  • Patient not or badly understanding French.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient with Myocardial Infarction
Device: 3D RA
3D RA is realised just after angioplasty.
Device: MRI
MRI is realised between 24h and 96h post angioplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
infarct size measured by RA
Time Frame: Day 1
Day 1
infarct size measured by MRI
Time Frame: Day 4
Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2013

Primary Completion (Actual)

September 7, 2013

Study Completion (Actual)

September 7, 2013

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Actual)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-749

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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