Text Size

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
  Purpose

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 Intervention Phase
Myocardial Infarction
 Drug: Technetium Tc99m Sestamibi
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: AIR-MI: Assessment of Ischemia and Remodeling Following Acute Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 74
Study Start Date: January 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162331

Locations
United States, Alabama
Local Institution
Birmingham, Alabama, United States
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States
United States, Tennessee
Local Institution
Nashville, Tennessee, United States
United States, Washington
Local Institution
Seattle, Washington, United States
Brazil
Local Institution
Curibita, Brazil
Local Institution
Sao Paolo, Brazil
Canada, Ontario
Local Institution
Ottawa, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Study Director: Qi Zhu, MD Lantheus Medical Imaging
  More Information

No publications provided

Responsible Party: Qi Zhu, MD Sr. Medical Director, Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00162331     History of Changes
Other Study ID Numbers: CARDIOLITE-413
Study First Received: September 9, 2005
Last Updated: April 14, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013