Back to resultsPhase Analysis and Obstructive CAD on Rubidium PET
Primary Purpose
Coronary Artery Disease
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Regadenoson
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Male or female patients
- referred for myocardial perfusion imaging for suspected obstructive CAD
- 18 years of age or older.
Exclusion Criteria:
- Contraindications to regadenoson radionuclide imaging including severe reactive airway disease, unstable crescendo angina, high grade AV block, caffeine within 24 hours
- Documented prior myocardial infarction
- Severe claustrophobia
- Patients who may be pregnant.
Sites / Locations
- Emory University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Regadenoson
Arm Description
Outcomes
Primary Outcome Measures
Stress/rest differences in global left ventricular mechanical contraction bandwidth.
The investigators will measure the percent change in global left ventricular mechanical contraction bandwidth between stress and rest perfusion imaging as measured by phase analysis.
Two patients were enrolled but the data were not analyzed.
Secondary Outcome Measures
Stress/rest differences in segmental left ventricular mechanical contraction bandwidth.
The investigators will measure the percent change in segmental (each of 3 major coronary arteries) left ventricular mechanical contraction bandwidth between stress and rest perfusion imaging as measured by phase analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01840696
Brief Title
Phase Analysis and Obstructive CAD on Rubidium PET
Official Title
Regional and Global Left Ventricular Mechanical Dyssynchrony in the Diagnosis of Obstructive Coronary Artery Disease on Rest and Regadenoson Stress Rubidium Myocardial Perfusion PET
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Withdrawn
Why Stopped
PI leaving facility
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Rubidium myocardial perfusion PET is an imaging test used to diagnose patients with abnormal blood flow to the heart secondary to narrowing of the heart vessels.
Phase analysis is a computer method that is applied after the PET test is done. It is used to determine when a region of the heart contracts relative to other heart regions in the heart beating cycle. Initial data suggest that regions of the heart with abnormal blood flow change the pattern of contraction from rest to stress conditions. That is, regions of the heart with abnormal blood supply become dyssynchronous when compared to the normal regions of the heart.
This study will investigate whether phase analysis may aid the visual interpretation of rubidium myocardial perfusion PET studies by determining the areas of the heart that are not beating in synchrony with the normal heart regions. This information will be used as a proxy for poor blood supply. The gold standard will be coronary angiography by which the percent narrowing of the heart vessels is assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regadenoson
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Regadenoson
Other Intervention Name(s)
Lexiscan
Intervention Description
Vasodilator stress testing
Primary Outcome Measure Information:
Title
Stress/rest differences in global left ventricular mechanical contraction bandwidth.
Description
The investigators will measure the percent change in global left ventricular mechanical contraction bandwidth between stress and rest perfusion imaging as measured by phase analysis.
Two patients were enrolled but the data were not analyzed.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Stress/rest differences in segmental left ventricular mechanical contraction bandwidth.
Description
The investigators will measure the percent change in segmental (each of 3 major coronary arteries) left ventricular mechanical contraction bandwidth between stress and rest perfusion imaging as measured by phase analysis.
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients
referred for myocardial perfusion imaging for suspected obstructive CAD
18 years of age or older.
Exclusion Criteria:
Contraindications to regadenoson radionuclide imaging including severe reactive airway disease, unstable crescendo angina, high grade AV block, caffeine within 24 hours
Documented prior myocardial infarction
Severe claustrophobia
Patients who may be pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Esteves, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase Analysis and Obstructive CAD on Rubidium PET
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