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Assessment of Myocardial Viability Using Multidetector Computed Tomography

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ClinicalTrials.gov Identifier: NCT00285064
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : October 15, 2008
Sponsor:
Collaborator:
Philips Medical Systems
Information provided by:
Rambam Health Care Campus

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: CT Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: Non-Invasive Assessment of Myocardial Viability Using Multidetector Computed Tomography Post Acute Myocardial Infarction
Study Start Date : January 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Prediction of viability from myocardial enhancement patterns

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT00285064


Locations
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Israel
Rambam Medical Center
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Philips Medical Systems
Investigators
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Principal Investigator: Jonathan Lessick, MD DSc Rambam Health Care Campus
More Information
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ClinicalTrials.gov Identifier: NCT00285064    
Other Study ID Numbers: ram1099_CTIL
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: October 15, 2008
Last Verified: February 2007
Keywords provided by Rambam Health Care Campus:
MDCT
viability
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases