Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by VA St. Louis Health Care System
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Medhat Osman MD, VA St. Louis Health Care System
ClinicalTrials.gov Identifier:
NCT02136706
First received: May 4, 2014
Last updated: May 10, 2014
Last verified: May 2014
  Purpose

Encouraged by the recent data published ,the investigators think that a waiting time of 10 minutes is feasible while preserving diagnostic accuracy and would like to assess the feasibility and diagnostic efficacy of W10 compared with W30 imaging in a pilot study. By combining W10 imaging with half-time acquisition, the time of the technetium-99m myocardial perfusion imaging procedure could be shortened by at least 50%, lasting only 40 minutes for W10 (10-minute waiting) imaging compared with 90 minutes for W30 imaging (30-minute waiting).

The investigators hypothesize that (1) W10 MPI is clinically feasible and tolerable by the patients, that (2) W10 MPI provides high image quality and that (3) W10 MPI provides diagnostic accuracy comparable to W30 MPI.


Condition Intervention
Coronary Artery Disease
Atherosclerosis
Procedure: Myocardial Perfusion imaging with 10 minute waiting period

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol: A Pilot Study

Resource links provided by NLM:


Further study details as provided by VA St. Louis Health Care System:

Primary Outcome Measures:
  • Visual and semi-quantitative evaluation of W10 and W30 studies. [ Time Frame: Day 1of testing ] [ Designated as safety issue: No ]
    The investigators will evaluate image quality of W10 and W30-qualitatively (visually) by 2 independent readers and semi-qualitatively by means of region of interest (ROI) count/pixels parameters of W10 and W30 data and compare their diagnostic accuracy for the diagnosis of myocardial ischemia and infarction.


Secondary Outcome Measures:
  • Tolerability Questionnaire [ Time Frame: Day 1 of testing ] [ Designated as safety issue: No ]
    Each patient will complete a total of 6 questionnaires on the day of testing before and after each stress W10 and W30 scanning. The participants will be asked to rate how they felt, and if present, how they perceived their headache during scanning. Patients will also be asked how they felt and how severe was their headache when comparing the rest W10 and W30 and the stress W10 and W30.

  • Feasibility of W10 by written documentation. [ Time Frame: Day 1 of testing ] [ Designated as safety issue: No ]
    By documenting any technical or clinical difficulties during the W10 procedure


Estimated Enrollment: 36
Study Start Date: June 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 10/30 min rest/stress
Rest and stress T99m-MPI obtained 10 minutes and 30 minutes after tracer injection. After the myocardial perfusion imaging the investigators will have 10 minute waiting period to take images and then wait the 30 minutes, standard of care to take the images.
Procedure: Myocardial Perfusion imaging with 10 minute waiting period
After the Myocardial Perfusion Imaging testing the investigators will wait 10 minutes to take images and then wait the 30 minute standard of care time to take images.

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ≥18 and ≤ 89 years of age of any race /ethnicity
  • Patient has undergone or is being scheduled for a clinically indicated CardiacCath with or without angioplasty
  • Patient may have suffered myocardial infarction more than 3 days before T99m-MPI
  • Patient may have undergone percutaneous transluminal coronary angioplasty (PTCA) or coronary stent placement more than 3 days prior to T99m-Myocardial Perfusion Imaging (MPI)
  • Interval between T99m-MPI and CardiacCath is within 30 days
  • Females cannot be pregnant or lactating
  • Women of no child-bearing potential (post-menopausal defined as amenorrhea ≥ 12 consecutive months, or because they have undergone successful surgical sterilization and deny current history of pregnancy and nursing). These subjects do not require serum pregnancy test on the day of the study
  • Women of childbearing potential will require a negative serum pregnancy test, performed on the day of the study
  • Provide signed Informed Consent prior to undergoing the study procedures

Exclusion Criteria:

  • Patients less than 18 and ≥89 years of age
  • Patient has been involved in any other investigative, radioactive research procedure within 7 days and during the study participation period
  • History of 2nd or 3rd degree Atrio-ventricular-block, or sinus node dysfunction unless the patients have a functioning artificial pacemaker
  • Current ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
  • Current unstable angina or cardiovascular instability
  • Current history of exacerbated Chronic Obstructive Pulmonary Disease (COPD) or asthma
  • Known hypersensitivity or contraindication to regadenoson or aminophylline
  • Use of caffeinated substance, dipyridamole-containing medication, aminophylline, or xanthines containing medication (e.g. theophylline) within the 12 hours prior to Lexiscan administration
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Medhat Osman MD, Professor of Radiology, Director of Nuclear Medicine and Pet/CT, VA St. Louis Health Care System
ClinicalTrials.gov Identifier: NCT02136706     History of Changes
Other Study ID Numbers: REGA-14A01
Study First Received: May 4, 2014
Last Updated: May 10, 2014
Health Authority: United States: Federal Government

Keywords provided by VA St. Louis Health Care System:
Stable coronary artery disease

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on September 16, 2014