Back to resultsCARDIOLITE-413: A Study for Patients Who Had a PCI for an Acute MI
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Technetium Tc99m Sestamibi
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Infarction
Eligibility 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.
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Outcomes
Primary Outcome Measures
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
To estimate the frequency of residual ischemia as assessed by stress myocardial perfusion imaging (MPI) in patients undergoing primary PCI for AMI.
To estimate the 6-month cardiac event rates (composite of death, another heart attack, hospitalization for heart failure, and irregular heart beats requiring treatment).
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.
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.
Full Information
NCT ID
NCT00162331
First Posted
September 9, 2005
Last Updated
April 14, 2011
Sponsor
Lantheus Medical Imaging
1. Study Identification
Unique Protocol Identification Number
NCT00162331
Brief Title
CARDIOLITE-413: A Study for Patients Who Had a PCI for an Acute MI
Official Title
AIR-MI: Assessment of Ischemia and Remodeling Following Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lantheus Medical Imaging
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Technetium Tc99m Sestamibi
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To estimate the frequency of residual ischemia as assessed by stress myocardial perfusion imaging (MPI) in patients undergoing primary PCI for AMI.
Title
To estimate the 6-month cardiac event rates (composite of death, another heart attack, hospitalization for heart failure, and irregular heart beats requiring treatment).
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi Zhu, MD
Organizational Affiliation
Lantheus Medical Imaging
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Local Institution
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Local Institution
City
Curibita
Country
Brazil
Facility Name
Local Institution
City
Sao Paolo
Country
Brazil
Facility Name
Local Institution
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
CARDIOLITE-413: A Study for Patients Who Had a PCI for an Acute MI
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