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

This study has been completed.

Sponsor:

Information provided by:

Lantheus Medical Imaging

ClinicalTrials.gov Identifier:

NCT00162331

First received: September 9, 2005

Last updated: April 14, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

April 14, 2011

Start Date ^ICMJE

January 2005

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00162331 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Myocardial Infarction

Intervention ^ICMJE

Drug: Technetium Tc99m Sestamibi

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Brazil, Canada

Administrative Information

NCT Number ^ICMJE

NCT00162331

Other Study ID Numbers ^ICMJE

CARDIOLITE-413

Has Data Monitoring Committee

Responsible Party

Qi Zhu, MD Sr. Medical Director, Lantheus Medical Imaging

Study Sponsor ^ICMJE

Lantheus Medical Imaging

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Qi Zhu, MD

Lantheus Medical Imaging

Information Provided By

Lantheus Medical Imaging

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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