Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty

This study has been completed.
Sponsor:
Information provided by:
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00162357
First received: September 9, 2005
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

The purpose of this clinical research study is determine if patients with diabetes that have undergone previous opening of a heart blockage may have a blockage that is not causing any symptoms that may be detected by imaging with Cardiolite.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Coronary Restenosis
Drug: Technetium Tc99m Sestamibi
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cardiolite-406; A Phase IV Open-Label, Randomized, Multi-Center Trial To Evaluate The Ability of Cardiolite Stress MPI to Detect Asymptomatic Restenosis in Diabetic Patients Who Have Undergone Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging

Secondary Outcome Measures:
  • Determine how often symptom-free heart blockages occur 5-6 months after opening in patients with Type II diabetes mellitus
  • Examine the relative value of ejection fraction, summed stress, rest, and difference MPI scores for identifying patients with cardiac events during 18 month follow-up.
  • Compare patient hospital and out-patient cost for cardiac care for each group of patients (MPI versus standard care).

Enrollment: 106
Study Start Date: April 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type II Diabetes on medication & angioplasty within the past 6 months.

Exclusion Criteria:

  • Myocardial infarction or repeat angioplasty with the past 5 months.
  • Unable to perform exercise or pharmacologic stress test.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162357

Locations
United States, Connecticut
Local Institution
Hartford, Connecticut, United States
Local Institution
Waterbury, Connecticut, United States
United States, Michigan
Local Institution
Grand Rapids, Michigan, United States
United States, New York
Local Institution
Roslyn, New York, United States
United States, Vermont
Local Institution
Burlington, Vermont, United States
United States, Virginia
Local Institution
Roanoke, Virginia, United States
United States, Wisconsin
Local Institution
Wausau, Wisconsin, United States
Puerto Rico
Local Institution
San Juan, Puerto Rico
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: NCT00162357     History of Changes
Other Study ID Numbers: CARDIOLITE-406
Study First Received: September 9, 2005
Last Updated: April 14, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Coronary Restenosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Technetium Tc 99m Sestamibi
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014