Study Stopped
PI leaving facility
Phase Analysis and Obstructive CAD on Rubidium PET
Regional and Global Left Ventricular Mechanical Dyssynchrony in the Diagnosis of Obstructive Coronary Artery Disease on Rest and Regadenoson Stress Rubidium Myocardial Perfusion PET
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2013
Shorter than P25 for phase_2 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2013
CompletedFirst Posted
Study publicly available on registry
April 26, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJune 2, 2014
May 1, 2014
7 months
April 16, 2013
May 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 12 months
Secondary Outcomes (1)
Stress/rest differences in segmental left ventricular mechanical contraction bandwidth.
Up to 12 months
Study Arms (1)
Regadenoson
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female patients
- referred for myocardial perfusion imaging for suspected obstructive CAD
- years of age or older.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (1)
Emory University Hospital
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabio Esteves, MD
Emory University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 16, 2013
First Posted
April 26, 2013
Study Start
October 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
June 2, 2014
Record last verified: 2014-05