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Evaluation of Infarct Size With 3D Rotational Angiography

Evaluation of Infarct Size With 3D Rotational Angiography

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02857985
Acronym
EVATIAR
Enrollment
8
Registered
2016-08-05
Start date
2013-03-09
Completion date
2013-09-07
Last updated
2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Myocardial Infarction, MRI, rotational angiography

Brief 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.

Interventions

DEVICE3D RA

3D RA is realised just after angioplasty.

DEVICEMRI

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frame
infarct size measured by RADay 1
infarct size measured by MRIDay 4

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026