Prospective Data Collection of IVMRI Cases (MIRACLE)
This study is not yet open for participant recruitment.
Verified November 2007 by TopSpin Medical
Information provided by:
First received: November 14, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
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.
Coronary Plaque Lipid Characterization
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||Prospective Data Collection in Clinical Cases Where Coronary Plaque Lipid Characterization by IVMRI Was Performed During Diagnostic or Interventional Catheterization Procedures
Primary Outcome Measures:
- LFI - Lipid Fraction Index [ Time Frame: 5 years ]
Secondary Outcome Measures:
- correlation between LFI and a set of predefined parameters [ Time Frame: 5 years ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
Intra Vascular Magnetic Resonance Imaging
Other Name: Cathamaran
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558441
|Sourasky Medical Center
|Tel-Aviv, Israel |
|Contact: Shmuel Banai, Prof. +972-3-6973395 email@example.com |
|Principal Investigator: Shmuel Banai, Prof. |
||William Wijns, Prof.
No publications provided
ClinicalTrials.gov processed this record on May 22, 2013
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 14, 2007
||November 14, 2007
||Israel: Ministry of Health