Clincosm LogoSign in Get a demo

Phase Analysis and Obstructive CAD on Rubidium PET

Sponsor
Emory University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01840696
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
7
Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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 Start Date :
Oct 1, 2013
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Regadenoson

Drug: Regadenoson
Vasodilator stress testing
Other Names:
  • Lexiscan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Stress/rest differences in global left ventricular mechanical contraction bandwidth. [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.

    Secondary Outcome Measures

    1. Stress/rest differences in segmental left ventricular mechanical contraction bandwidth. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory University Hospital Atlanta Georgia United States 30322

    Sponsors and Collaborators

    • Emory University

    Investigators

    • Principal Investigator: Fabio Esteves, MD, Emory University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fabio Esteves, MD, Associate Professor, Emory University
    ClinicalTrials.gov Identifier:
    NCT01840696
    Other Study ID Numbers:
    • IRB00062632
    • REGA12I11
    First Posted:
    Apr 26, 2013
    Last Update Posted:
    Jun 2, 2014
    Last Verified:
    May 1, 2014
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Coronary Disease
    Regadenoson

    Study Results

    No Results Posted as of Jun 2, 2014