Back to resultsFeasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol
Primary Purpose
Coronary Artery Disease, Atherosclerosis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Myocardial Perfusion imaging with 10 minute waiting period
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Stable coronary artery disease
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
10/30 min rest/stress
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Tolerability Questionnaire
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.
By documenting any technical or clinical difficulties during the W10 procedure
Full Information
NCT ID
NCT02136706
First Posted
May 4, 2014
Last Updated
December 14, 2015
Sponsor
Medhat Osman MD
Collaborators
Astellas Pharma US, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02136706
Brief Title
Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol
Official Title
Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor and site were unable to complete a final contract to support the study
Study Start Date
December 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Medhat Osman MD
Collaborators
Astellas Pharma US, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Atherosclerosis
Keywords
Stable coronary artery disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10/30 min rest/stress
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Myocardial Perfusion imaging with 10 minute waiting period
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual and semi-quantitative evaluation of W10 and W30 studies.
Description
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.
Time Frame
Day 1of testing
Secondary Outcome Measure Information:
Title
Tolerability Questionnaire
Description
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.
Time Frame
Day 1 of testing
Title
Feasibility of W10 by written documentation.
Description
By documenting any technical or clinical difficulties during the W10 procedure
Time Frame
Day 1 of testing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol
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