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Phase Analysis and Obstructive CAD on Rubidium PET

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01840696
Recruitment Status : Withdrawn (PI leaving facility)
First Posted : April 26, 2013
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
Fabio Esteves, MD, Emory University

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
Coronary Artery Disease Drug: Regadenoson Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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 : October 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Regadenoson

Arm Intervention/treatment
Experimental: Regadenoson Drug: Regadenoson
Vasodilator stress testing
Other Name: Lexiscan




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840696


Locations
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United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Fabio Esteves, MD Emory University

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Responsible Party: Fabio Esteves, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT01840696    
Other Study ID Numbers: IRB00062632
REGA12I11 ( Other Identifier: Other )
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Regadenoson
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs