Prospective Data Collection of IVMRI Cases (MIRACLE)

November 14, 2007 updated by: TopSpin Medical

Prospective Data Collection in Clinical Cases Where Coronary Plaque Lipid Characterization by IVMRI Was Performed During Diagnostic or Interventional Catheterization Procedures

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Device: IVMRI
Intra Vascular Magnetic Resonance Imaging
Other Names:
  • Cathamaran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LFI - Lipid Fraction Index
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
correlation between LFI and a set of predefined parameters
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TopSpin Medical

Investigators

  • Principal Investigator: William Wijns, Prof., OLV Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

November 14, 2007

First Submitted That Met QC Criteria

November 14, 2007

First Posted (Estimate)

November 15, 2007

Study Record Updates

Last Update Posted (Estimate)

November 15, 2007

Last Update Submitted That Met QC Criteria

November 14, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • PCL-1.2-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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