Evaluation of Infarct Size With 3D Rotational Angiography

NCT02857985 | Completed

• 1 other identifier: 2012-749
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

Myocardial Infarction; MRI; rotational angiography

Outcome Measures

Primary Outcomes (2)

• infarct size measured by RA

  Day 1

• infarct size measured by MRI

  Day 4

Study Arms (1)

Patient with Myocardial Infarction

EXPERIMENTAL

Device: 3D RA; Device: MRI

Interventions

3D RA DEVICE

3D RA is realised just after angioplasty.

Patient with Myocardial Infarction

MRI DEVICE

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

Patient with Myocardial Infarction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Louis Pradel

Bron, 69500, France

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 5, 2016
• Study Start: March 9, 2013
• Primary Completion: September 7, 2013
• Study Completion: September 7, 2013
• Last Updated: January 29, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)