Assessment of Myocardial Viability Using Multidetector Computed Tomography

This study has been completed.
Sponsor:
Collaborator:
Philips Medical Systems
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00285064
First received: January 30, 2006
Last updated: October 11, 2008
Last verified: February 2007
  Purpose

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 Intervention
Myocardial Infarction
Procedure: CT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Non-Invasive Assessment of Myocardial Viability Using Multidetector Computed Tomography Post Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Prediction of viability from myocardial enhancement patterns

Estimated Enrollment: 20
Study Start Date: January 2006
Study Completion Date: May 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00285064

Locations
Israel
Rambam Medical Center
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Philips Medical Systems
Investigators
Principal Investigator: Jonathan Lessick, MD DSc Rambam Health Care Campus
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00285064     History of Changes
Other Study ID Numbers: ram1099_CTIL
Study First Received: January 30, 2006
Last Updated: October 11, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
MDCT
viability

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014