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CARDIOLITE-413: A Study for Patients Who Had a PCI for an Acute MI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00162331
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : April 15, 2011
Sponsor:
Information provided by:
Lantheus Medical Imaging

Brief Summary:
The purpose of this clinical study is to learn if there are any changes in how blood gets to your heart muscle and if your heart size changed after your heart attack.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Technetium Tc99m Sestamibi Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: AIR-MI: Assessment of Ischemia and Remodeling Following Acute Myocardial Infarction
Study Start Date : January 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources




Primary Outcome Measures :
  1. To better understand the interactions between the abnormalities in blood supply from the small vessels of the heart to the heart muscle after a heart attack and the changes in heart size 6 months after the heart attack.

Secondary Outcome Measures :
  1. To estimate the frequency of residual ischemia as assessed by stress myocardial perfusion imaging (MPI) in patients undergoing primary PCI for AMI.
  2. To estimate the 6-month cardiac event rates (composite of death, another heart attack, hospitalization for heart failure, and irregular heart beats requiring treatment).
  3. To determine the relationship between changes (from baseline) in LV systolic volume index and LVEF, as measured by gated SPECT imaging 6 months following reperfusion, and the presence and severity of residual ischemia.
  4. To measure the performance of angiographic parameters of success of reperfusion therapy (TIMI frame count and TIMI myocardial perfusion grade) in predicting the presence of residual ischemia.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing primary or rescue PCI for acute MI with ECG evidence of a large territory at risk.

Exclusion Criteria:

  • History of prior MI or CABG surgery, persistent LBBB, Atrial Fibrillation, End stage renal disease, Weight > 350 lbs.

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): NCT00162331


Locations
United States, Alabama
Local Institution
Birmingham, Alabama, United States
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States
United States, Tennessee
Local Institution
Nashville, Tennessee, United States
United States, Washington
Local Institution
Seattle, Washington, United States
Brazil
Local Institution
Curibita, Brazil
Local Institution
Sao Paolo, Brazil
Canada, Ontario
Local Institution
Ottawa, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Study Director: Qi Zhu, MD Lantheus Medical Imaging

Responsible Party: Qi Zhu, MD Sr. Medical Director, Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00162331     History of Changes
Other Study ID Numbers: CARDIOLITE-413
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Technetium Tc 99m Sestamibi
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action