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
Sponsor:
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
  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
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

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 October 19, 2014