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OpenTrials
Completed

NCT Number: NCT00162357

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Coronary Disease Coronary Restenosis Coronary Stenosis Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Local Institution, San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Technetium Tc99m Sestamibi

Drug

Primary outcomes

  1. Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging

Secondary outcomes

  1. Determine how often symptom-free heart blockages occur 5-6 months after opening in patients with Type II diabetes mellitus

  2. 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.

  3. Compare patient hospital and out-patient cost for cardiac care for each group of patients (MPI versus standard care).

Sponsors and collaborators

Lead sponsor

Lantheus Medical Imaging

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 13, 2005
Registry last updated
Apr 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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