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CompletedNCT02857985EVATIARUpdated Jan 29, 2018

Evaluation of Infarct Size With 3D Rotational Angiography

An interventional study of 3D RA and MRI in Myocardial Infarction, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-29.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 years 4 months after the study started (first participant enrolled Mar 2013, registered Aug 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Myocardial Infarction

Keywords

  • Myocardial Infarction
  • MRI
  • rotational angiography
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 8 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Patient with Myocardial Infarction

    Device: 3D RA · Device: MRI

Interventions

  • Device3D RA

    3D RA is realised just after angioplasty.

  • DeviceMRI

    MRI is realised between 24h and 96h post angioplasty.

06

What researchers measure

Primary outcomes

  1. infarct size measured by RA

    Time frame: Day 1

  2. infarct size measured by MRI

    Time frame: Day 4

07

Study locations

1 site
  • Hôpital Louis Pradel
    Bron, 69500, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02857985
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Aug 5, 2016
Start date
Mar 9, 2013
Primary completion
Sep 7, 2013
Completion
Sep 7, 2013
Last update
Jan 29, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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