Evaluation of Infarct Size With 3D Rotational Angiography

Myocardial Infarction Clinical Trial

— EVATIAR  

Official title:

Evaluation of Infarct Size With 3D Rotational Angiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857985
• Other study ID #: 2012-749
• Status: Completed
• Phase: N/A
• First received: August 3, 2016
• Last updated: January 26, 2018
• Start date: March 9, 2013
• Est. completion date: September 7, 2013

Study information

• Verified date: January 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 7, 2013
• Est. primary completion date: September 7, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Device:
• 3D RA
3D RA is realised just after angioplasty.
• MRI
MRI is realised between 24h and 96h post angioplasty.

Locations

Country	Name	City	State
France	Hôpital Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infarct size measured by RA		Day 1
Primary	infarct size measured by MRI		Day 4