NCT Number: NCT00162331
CARDIOLITE-413: A Study for Patients Who Had a PCI for an Acute MI
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Local Institution, Curibita, Brazil
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
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
-
To estimate the frequency of residual ischemia as assessed by stress myocardial perfusion imaging (MPI) in patients undergoing primary PCI for AMI.
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To estimate the 6-month cardiac event rates (composite of death, another heart attack, hospitalization for heart failure, and irregular heart beats requiring treatment).
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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.
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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.
Sponsors and collaborators
Lead sponsor
Lantheus Medical Imaging
Industry
Registry information
Official study title
AIR-MI: Assessment of Ischemia and Remodeling Following Acute Myocardial Infarction
Important dates
- Study start
- 2005
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Sep 13, 2005
- Registry last updated
- Apr 15, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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