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

April 14, 2011 updated by: Lantheus Medical Imaging

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Curibita, Brazil
        • Local Institution
      • Sao Paolo, Brazil
        • Local Institution
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
        • Local Institution
      • Toronto, Ontario, Canada
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States
        • Local Institution
    • Tennessee
      • Nashville, Tennessee, United States
        • Local Institution
    • Washington
      • Seattle, Washington, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lantheus Medical Imaging

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

April 15, 2011

Last Update Submitted That Met QC Criteria

April 14, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARDIOLITE-413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Technetium Tc99m Sestamibi

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe