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

• Sponsor: Lantheus Medical Imaging (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00162331
• Collaborator: (none)
• Enrollment: 74
• Locations: 8
• Duration (Months): 29.9
• Patients Per Site: 9.3
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Drug: Technetium Tc99m Sestamibi	Phase 4

Study Design

• Study Type: Interventional
• 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: Jan 1, 2005
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Birmingham	Alabama	United States
2	Local Institution	Boston	Massachusetts	United States
3	Local Institution	Nashville	Tennessee	United States
4	Local Institution	Seattle	Washington	United States
5	Local Institution	Curibita		Brazil
6	Local Institution	Sao Paolo		Brazil
7	Local Institution	Ottawa	Ontario	Canada
8	Local Institution	Toronto	Ontario	Canada

Sponsors and Collaborators

• Lantheus Medical Imaging

Investigators

• Study Director: Qi Zhu, MD, Lantheus Medical Imaging

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00162331
• Other Study ID Numbers: CARDIOLITE-413
• First Posted: Sep 13, 2005
• Last Update Posted: Apr 15, 2011
• Last Verified: Apr 1, 2011

• Additional relevant MeSH terms: Myocardial Infarction; Infarction; Technetium Tc 99m Sestamibi

Study Results

No Results Posted as of Apr 15, 2011