Evaluation of Myocardial Ischemia Using Standard Single Photon Emission Computed Tomography (SPECT) With Regadenoson and Simultaneous Cardiac Echocardiography (Lexi-Echo)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Aiden Abidov, University of Arizona
ClinicalTrials.gov Identifier:
NCT01150578
First received: March 9, 2010
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

This study is for people who have a SPECT scan (nuclear imaging of the blood flow to the heart muscle) ordered by their medical doctors. As part of the SPECT scan, they will have been given a drug called regadenoson to widen and expand the blood vessels bringing blood to the heart muscle. The SPECT pictures of the heart are taken about an hour after the regadenoson is put into an arm vein through an IV. In this study, additional echo pictures will be taken and compared to the SPECT pictures.

The aim of the study is to see if the echo pictures work as well as SPECT to measure the blood flow to the heart muscle.


Condition Intervention
Myocardial Ischemia
Drug: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lexi-Echo - a Rapid, Portable, Non-radiating Diagnostic Test for Myocardial Ischemia That is Accurate Relative to Simultaneously Obtained Nuclear SPECT MPI

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Determine the diagnostic accuracy of state-of-the-art echocardiography after regadenoson administration (Lexi-Echo) in the evaluation of myocardial ischemia (determined by the reference standard myocardial perfusion imaging SPECT). [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Obtain short term (6 month) outcomes: hospitalization for ischemia or infarction, coronary angiographic (invasive or noninvasive) correlation when available for clinical indications, and mortality. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Perform a limited cost-analysis of the two diagnostic testing options [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Obtain hemodynamic Doppler Echo variables to investigate the acute hemodynamic alterations during Lexiscan infusion. [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 380
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lexi-Echo pilot
Appropriate patients at University of Arizona Medical Center stress imaging laboratory who have a routine regadenoson SPECT nuclear scan will have simultaneous cardiac echo images obtained.
Drug: No intervention
No intervention
Other Name: No intervention

Detailed Description:

This is a single center, prospective, non-randomized, comparative, same-setting study of Lexiscan MPI SPECT versus state-of-the-art echocardiography. Lexiscan SPECT MPI will be performed per routine clinical protocol with Lexiscan administered as per package insert (0.4 mg in 5 ml IV push over 10 seconds followed by a 5 ml saline flush). Simultaneous echo/Doppler will be obtained immediately before (baseline), during and immediately post (peak vasodilation) using conventional techniques.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients referred to a University of Arizona / Sarver Heart Center / University Medical Center stress imaging laboratory and scheduled to receive a regadenoson SPECT nuclear scan.

Criteria

Inclusion Criteria:

  • Patients referred to a University of Arizona/Sarver Heart Center/University Medical Center stress imaging laboratory and scheduled to receive a regadenoson SPECT nuclear scan.

Exclusion Criteria:

  • Patients unable or unwilling to undergo the clinically necessary stress test or to provide informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150578

Locations
United States, Arizona
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
Aiden Abidov
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Aiden Abidov, MD, PhD Associate Professor of Medicine and Radiology
  More Information

No publications provided

Responsible Party: Aiden Abidov, Associate Professor of Medicine and Radiology, University of Arizona
ClinicalTrials.gov Identifier: NCT01150578     History of Changes
Other Study ID Numbers: Lexi-Echo2010
Study First Received: March 9, 2010
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arizona:
Echocardiography, 2D
speckle tracking
Lexiscan
regadenoson
Myocardial ischemia
Myocardial perfusion imaging
cost and cost analysis
Cardiac-Gated SPECT Imaging
Echocardiography

Additional relevant MeSH terms:
Coronary Artery Disease
Ischemia
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Pathologic Processes
Vascular Diseases
Regadenoson
Adenosine A2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents
Purinergic Agonists
Purinergic P1 Receptor Agonists

ClinicalTrials.gov processed this record on October 20, 2014