Prospective Data Collection of IVMRI Cases (MIRACLE)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by TopSpin Medical.
Recruitment status was Not yet recruiting
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558441
|Sourasky Medical Center
|Tel-Aviv, Israel |
|Contact: Shmuel Banai, Prof. +972-3-6973395 firstname.lastname@example.org |
|Principal Investigator: Shmuel Banai, Prof. |
||William Wijns, Prof.
No publications provided
ClinicalTrials.gov processed this record on July 01, 2015
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 14, 2007
||November 14, 2007
||Israel: Ministry of Health