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Prospective Data Collection of IVMRI Cases (MIRACLE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by TopSpin Medical.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00558441
First Posted: November 15, 2007
Last Update Posted: November 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
TopSpin Medical
  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: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00558441     History of Changes
Other Study ID Numbers: PCL-1.2-002
First Submitted: November 14, 2007
First Posted: November 15, 2007
Last Update Posted: November 15, 2007
Last Verified: November 2007