Prospective Data Collection of IVMRI Cases
Not Applicable
- Conditions
- Coronary Plaque Lipid Characterization
- Interventions
- Device: IVMRI
- Registration Number
- NCT00558441
- Lead Sponsor
- TopSpin Medical
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 IVMRI -
- Primary Outcome Measures
Name Time Method LFI - Lipid Fraction Index 5 years
- Secondary Outcome Measures
Name Time Method correlation between LFI and a set of predefined parameters 5 years
Trial Locations
- Locations (1)
Sourasky Medical Center
🇮🇱Tel-Aviv, Israel