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

Myocardial Infarction Clinical Trial

Official title:

AIR-MI: Assessment of Ischemia and Remodeling Following Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162331
• Other study ID #: CARDIOLITE-413
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: April 14, 2011
• Start date: January 2005
• Est. completion date: July 2007

Study information

• Verified date: April 2011
• Source: Lantheus Medical Imaging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Technetium Tc99m Sestamibi

Locations

Country	Name	City	State
Brazil	Local Institution	Curibita
Brazil	Local Institution	Sao Paolo
Canada	Local Institution	Ottawa	Ontario
Canada	Local Institution	Toronto	Ontario
United States	Local Institution	Birmingham	Alabama
United States	Local Institution	Boston	Massachusetts
United States	Local Institution	Nashville	Tennessee
United States	Local Institution	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Lantheus Medical Imaging

Countries where clinical trial is conducted

United States,  Brazil,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To estimate the frequency of residual ischemia as assessed by stress myocardial perfusion imaging (MPI) in patients undergoing primary PCI for AMI.
Secondary	To estimate the 6-month cardiac event rates (composite of death, another heart attack, hospitalization for heart failure, and irregular heart beats requiring treatment).
Secondary	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.
Secondary	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.