Prospective Data Collection of IVMRI Cases

Coronary Plaque Lipid Characterization Clinical Trial

— MIRACLE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00558441
• Other study ID #: PCL-1.2-002
• Status: Not yet recruiting
• Phase: N/A
• First received: November 14, 2007
• Last updated: November 14, 2007
• Start date: November 2007
• Est. completion date: November 2013

Study information

• Verified date: November 2007
• Source: TopSpin Medical
• Contact: Sharon Sax
• Phone: +972-54-6603112
• Email: sharons[@]topspin.co.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Plaque Lipid Characterization

Intervention

Device:
• IVMRI
Intra Vascular Magnetic Resonance Imaging

Locations

Country	Name	City	State
Israel	Sourasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
TopSpin Medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LFI - Lipid Fraction Index		5 years
Secondary	correlation between LFI and a set of predefined parameters		5 years