CARDIOLITE-413: A Study for Patients Who Had a PCI for an Acute MI
AIR-MI: Assessment of Ischemia and Remodeling Following Acute Myocardial Infarction
1 other identifier
interventional
74
3 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2005
Typical duration for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedApril 15, 2011
April 1, 2011
2.5 years
September 9, 2005
April 14, 2011
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (4)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Undergoing primary or rescue PCI for acute MI with ECG evidence of a large territory at risk.
You may not qualify if:
- History of prior MI or CABG surgery, persistent LBBB, Atrial Fibrillation, End stage renal disease, Weight \> 350 lbs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Local Institution
Birmingham, Alabama, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
Nashville, Tennessee, United States
Local Institution
Seattle, Washington, United States
Local Institution
Curibita, Brazil
Local Institution
São Paulo, Brazil
Local Institution
Ottawa, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Qi Zhu, MD
Lantheus Medical Imaging
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 13, 2005
Study Start
January 1, 2005
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
April 15, 2011
Record last verified: 2011-04