Myocardial IschemiaLexi-EchoNCT01150578
Evaluation of Myocardial Ischemia Using Standard Single Photon Emission Computed Tomography (SPECT) With Regadenoson and Simultaneous Cardiac Echocardiography
An observational study of Myocardial Ischemia, run by Aiden Abidov at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients unable or unwilling to undergo the clinically necessary stress test or to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Medical Center
Tucson, Arizona, 85724
About this study
Official title: Lexi-Echo - a Rapid, Portable, Non-radiating Diagnostic Test for Myocardial Ischemia That is Accurate Relative to Simultaneously Obtained Nuclear SPECT MPI
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.
Read the 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.
- Conditions
- Myocardial Ischemia
- Being tested
- No intervention
- Keywords
- Echocardiography, 2D, speckle tracking, Lexiscan, regadenoson, Myocardial ischemia, Myocardial perfusion imaging, cost and cost analysis, Cardiac-Gated SPECT Imaging, Echocardiography
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 minutes
Secondary outcomes (3)
Obtain short term (6 month) outcomes: hospitalization for ischemia or infarction, coronary angiographic (invasive or noninvasive) correlation when available for clinical indications, and mortality.
Measured: 6 months
Perform a limited cost-analysis of the two diagnostic testing options
Measured: 6 months
Obtain hemodynamic Doppler Echo variables to investigate the acute hemodynamic alterations during Lexiscan infusion.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startDec 2011
- Primary completionDec 2014
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aiden Abidov
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Responsible party
- Sponsor-investigator, Aiden Abidov, University of Arizona
- Investigators
- Aiden Abidov, MD, PhD, Principal investigator, Associate Professor of Medicine and Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150578
- Sponsor's protocol ID
- Lexi-Echo2010
- Acronym
- Lexi-Echo
- Status last verified
- Nov 2015
- First submitted
- 9 Mar 2010
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lexi-Echo - a Rapid, Portable, Non-radiating Diagnostic Test for Myocardial Ischemia That is Accurate Relative to Simultaneously Obtained Nuclear SPECT MPI
- ClinicalTrials.gov ID
- NCT01150578
- Acronym / sponsor ID
- Lexi-Echo / Lexi-Echo2010
- Conditions
- Myocardial Ischemia
- Keywords
- Echocardiography, 2D, speckle tracking, Lexiscan, regadenoson, Myocardial ischemia, Myocardial perfusion imaging, cost and cost analysis, Cardiac-Gated SPECT Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Aiden AbidovUniversity, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Dec 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lexi-Echo pilot | – | Drug: No interventionAppropriate 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients unable or unwilling to undergo the clinically necessary stress test or to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Drug | Lexi-Echo pilot |
Primary outcome
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
3 secondary outcomes
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
Perform a limited cost-analysis of the two diagnostic testing options
Time frame: 6 months
Obtain hemodynamic Doppler Echo variables to investigate the acute hemodynamic alterations during Lexiscan infusion.
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aiden Abidov, MD, PhD principal investigator
Associate Professor of Medicine and Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia, run by Aiden Abidov at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.