Evaluation of Myocardial Ischemia Using Standard Single Photon Emission Computed Tomography (SPECT) With Regadenoson and Simultaneous Cardiac Echocardiography (Lexi-Echo)
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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 |
- 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 ]
- 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 Primary Completion Date: | December 2013 (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 |
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.
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| United States, Arizona | |
| University of Arizona Medical Center | |
| Tucson, Arizona, United States, 85724 | |
| 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: | June 6, 2013 |
| 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:
|
Myocardial Ischemia Coronary Artery Disease Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes |
Regadenoson Adenosine A2 Receptor Antagonists Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013