Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol

NCT02136706 | Withdrawn

• 1 other identifier: REGA-14A01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Artery Disease; Atherosclerosis

Keywords

Stable coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Visual and semi-quantitative evaluation of W10 and W30 studies.

  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.

  Day 1of testing

Secondary Outcomes (2)

• Tolerability Questionnaire

  Day 1 of testing

• Feasibility of W10 by written documentation.

  Day 1 of testing

Study Arms (1)

10/30 min rest/stress

NO INTERVENTION

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

Interventions

Myocardial Perfusion imaging with 10 minute waiting period PROCEDURE

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.

10/30 min rest/stress

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medhat Osman MD: lead
• Astellas Pharma US, Inc.: collaborator

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology, Director of Nuclear Medicine and Pet/CT

Study Record Dates

• First Submitted: May 4, 2014
• First Posted: May 13, 2014
• Study Start: December 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2017
• Last Updated: December 16, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share