Evaluation of Infarct Size With 3D Rotational Angiography

NCT ID: NCT02857985

Last Updated: 2018-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-09
• Study Completion Date: 2013-09-07

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.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient with Myocardial Infarction

Group Type: EXPERIMENTAL

3D RA

Intervention Type: DEVICE

3D RA is realised just after angioplasty.

MRI

Intervention Type: DEVICE

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

Interventions

3D RA

3D RA is realised just after angioplasty.

Intervention Type: DEVICE

MRI

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Louis Pradel

Bron, , France

Countries

France

Other Identifiers

2012-749

Identifier Type: -

Identifier Source: org_study_id