Phase Analysis and Obstructive CAD on Rubidium PET

May 29, 2014 updated by: Fabio Esteves, MD, Emory University

Regional and Global Left Ventricular Mechanical Dyssynchrony in the Diagnosis of Obstructive Coronary Artery Disease on Rest and Regadenoson Stress Rubidium Myocardial Perfusion PET

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regadenoson
Drug: Regadenoson
Vasodilator stress testing
Other Names:
  • Lexiscan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress/rest differences in global left ventricular mechanical contraction bandwidth.
Time Frame: Up to 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress/rest differences in segmental left ventricular mechanical contraction bandwidth.
Time Frame: Up to 12 months
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.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Fabio Esteves, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

April 16, 2013

First Submitted That Met QC Criteria

April 25, 2013

First Posted (Estimate)

April 26, 2013

Study Record Updates

Last Update Posted (Estimate)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 29, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00062632
  • REGA12I11 (Other Identifier: Other)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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