Assessment of Myocardial Viability Using Multidetector Computed Tomography
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Infarction focused on measuring MDCT, viability
Eligibility Criteria
Inclusion Criteria: acute ST elevation myocardial infarction after primary angioplasty Exclusion Criteria: iodine allergy renal failure old MI arrhythmia inability to perform 20 second breath-hold
Sites / Locations
- Rambam Medical Center
Outcomes
Primary Outcome Measures
Prediction of viability from myocardial enhancement patterns
Secondary Outcome Measures
Full Information
NCT ID
NCT00285064
First Posted
January 30, 2006
Last Updated
October 11, 2008
Sponsor
Rambam Health Care Campus
Collaborators
Philips Medical Systems
1. Study Identification
Unique Protocol Identification Number
NCT00285064
Brief Title
Assessment of Myocardial Viability Using Multidetector Computed Tomography
Official Title
Non-Invasive Assessment of Myocardial Viability Using Multidetector Computed Tomography Post Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rambam Health Care Campus
Collaborators
Philips Medical Systems
4. Oversight
5. Study Description
Brief Summary
To perform a comprehensive evaluation of multidetector CT myocardial enhancement patterns in patients with an acute ST elevation MI. In particular we plan to assess the relationship between regions with early hypoperfusion and/or late hyperenhancement, and myocardial viability.
Detailed Description
20 patients admitted to ICCU with ST elevation MI, and treated with primary angioplasty on admission, will undergo between day 2 and 7 post-MI the following exams: a) multidetector CT: regular scan plus late scan at 10 minutes, to evaluate coronary arteries, regional function and myocardial enhancement, b) echocardiography with echo-contrast to evaluate function and size of abnormally contracting region and remodeling, c) nuclear studies: rest early and late Thallium SPECT, to evaluate perfusion and viability. At 3 months a second echo will be performed to assess recovery of abnormal segments. The perfusion defects on MSCT will be compared with the other modalities and at 3 months will be used to evaluate recovery of myocardial function i.e. viability. Parameters that will be evaluated include opacity of hypoenhanced segments, ratio of normal to abnormal segments, change in opacity between early and late scans, size and transmurality of hypoenhanced segments, and their relation to regional contraction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
MDCT, viability
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
CT
Primary Outcome Measure Information:
Title
Prediction of viability from myocardial enhancement patterns
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute ST elevation myocardial infarction
after primary angioplasty
Exclusion Criteria:
iodine allergy
renal failure
old MI
arrhythmia
inability to perform 20 second breath-hold
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Lessick, MD DSc
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Assessment of Myocardial Viability Using Multidetector Computed Tomography
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