Evaluation of Infarct Size With 3D Rotational Angiography

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Louis Pradel

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D RA

Device

3D RA is realised just after angioplasty.

MRI

Device

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

Primary outcomes

infarct size measured by RA

Time frame: Day 1
infarct size measured by MRI

Time frame: Day 4

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: EVATIAR

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Aug 5, 2016
Registry last updated: Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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