Prospective Data Collection of IVMRI Cases (MIRACLE)
This study is not yet open for participant recruitment.
Verified November 2007 by TopSpin Medical
Sponsor:
TopSpin Medical
Information provided by:
TopSpin Medical
ClinicalTrials.gov Identifier:
NCT00558441
First received: November 14, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Coronary Plaque Lipid Characterization |
Device: IVMRI |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Prospective Data Collection in Clinical Cases Where Coronary Plaque Lipid Characterization by IVMRI Was Performed During Diagnostic or Interventional Catheterization Procedures |
Further study details as provided by TopSpin Medical:
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: | 1000 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2013 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Device: IVMRI
Intra Vascular Magnetic Resonance Imaging
Other Name: Cathamaran
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558441
Contacts
| Contact: Sharon Sax | +972-54-6603112 | sharons@topspin.co.il |
Locations
| Israel | |
| Sourasky Medical Center | Not yet recruiting |
| Tel-Aviv, Israel | |
| Contact: Shmuel Banai, Prof. +972-3-6973395 shmuelb@tasmc.health.gov.il | |
| Principal Investigator: Shmuel Banai, Prof. | |
Sponsors and Collaborators
TopSpin Medical
Investigators
| Principal Investigator: | William Wijns, Prof. | OLV hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00558441 History of Changes |
| Other Study ID Numbers: | PCL-1.2-002 |
| Study First Received: | November 14, 2007 |
| Last Updated: | November 14, 2007 |
| Health Authority: | Israel: Ministry of Health |
ClinicalTrials.gov processed this record on May 22, 2013