Coronary Plaque Lipid Characterization
Conditions
Brief summary
The study purpose is to prospectively collect data for a set of predefined variables in clinical cases where coronary plaque lipid characterization by IVMRI was performed during diagnostic or interventional procedures in order to gather incremental information beyond angiography and other diagnostic modalities.
Interventions
DEVICEIVMRI
Intra Vascular Magnetic Resonance Imaging
Sponsors
TopSpin Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* An adult patient ≥ 18 years old. * The patient, or legal guardian, has been informed of the nature of the study, agrees to its provisions, and has sign the approved informed consent. * The patient and the treating physician agree to attend the follow-ups as defined in the study protocol. * Indication for diagnostic and/or interventional procedure. * Lesions in a native vessels where IVMRI interrogation may provide additional information beyond angiography and other diagnostic tools.
Exclusion criteria
* Culprit lesions within 48 hours following STEMI. * Tortuous vessels, calcified or thrombotic lesions. * Significant stenosis of an unprotected left main coronary artery. * IVMRI interrogation of an unprotected left main coronary artery. * Patients with pacemaker or cardioverter defibrillator. * The patient is suffering from transplant mediated coronary artery disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LFI - Lipid Fraction Index | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| correlation between LFI and a set of predefined parameters | 5 years |
Countries
Israel
Contacts
Primary ContactSharon Sax
Outcome results
None listed