Increased Right Ventricular Radiotracer UptakeRVuptakeLexiNCT01697995
Stress Induced Right Ventricular Uptake on Lexiscan Stress MPI
An observational study of Increased Right Ventricular Radiotracer Uptake, run by Aiden Abidov at 1 site in United States.
Trial summary
The objectives of this study are to determine the: 1. Diagnostic value of stress induced RV changes on Lexiscan stress MPI as compared to Exercise stress MPI in predicting a significant CAD. 2. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Increased Right Ventricular Radiotracer Uptake
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2016
- 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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Retrospective population (approximately 300 charts to be reviewed) * Patients with MPI and 2D Echocardiogram within one month of the stress testing in calendar year 2010 at University Medical Center, Tucson AZ. * 18 years or older 2. Prospective population (approximately 350 subjects to be recruited) * Patients scheduled for MPI at University Medical Center, Tucson AZ, and invited to participate in this study. * 18 years to 89 years old
Who may be able to join
- Retrospective population (approximately 300 charts to be reviewed)
- Patients with MPI and 2D Echocardiogram within one month of the stress testing in calendar year 2010 at University Medical Center, Tucson AZ.
- 18 years or older.
- Prospective population (approximately 350 subjects to be recruited)
- Patients scheduled for MPI at University Medical Center, Tucson AZ.
- 18 years to 89 years old
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- Exclusion Criteria (applied to both retrospective and prospective arms):
- patients with nondiagnostic or technically defective MPI
- incomplete clinical data
- severe valvular heart disease
- complex congenital heart disease
- life expectancy less than one year at the time of the index MPI
- unable to follow up (absence of permanent address)
- Known prisoners, pregnant women and cognitively impaired patients.
Who cannot join
None listed.
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: Diagnostic and Prognostic Value of the Stress Induced Right Ventricular Uptake on Lexiscan Stress MPI in Patients With Known or Suspected Coronary Artery Disease (CAD).
The objectives of this study are to determine the:
- Diagnostic value of stress induced RV changes on Lexiscan stress MPI as compared to Exercise stress MPI in predicting a significant CAD.
- Prognostic value of stress induced RV changes on Lexiscan stress MPI in predicting adverse short-term and long-term clinical outcomes after the index test.
Read the detailed description
Phase 1: Retrospective data collection/analysis All Lexiscan and exercise MPI images on patients performed for clinical indications in calendar year 2010 who had subsequent coronary angiogram within 3 months after index MPI will be retrieved for review by two experts. We will identify different types of RV uptake and RV overload during stress as well as presence or absence of these changes on resting images. Analysis will include increased RV uptake, enlargement, hypertrophy, thinning of RV and flattening of the interventricular septum. Diagnostic performance (sensitivity, specificity and diagnostic accuracy) of the identified pathological RV phenotypes in identifying severe and extensive disease will be evaluated by comparison with contrary angiograms. Comparison of the set of parameters identifying pathological RV changes, identifying normal and abnormal values of these novel ancillary markers, as well as assessing their diagnostic accuracy in patients with suspected and known CAD during vasodilator stress versus exercise stress MPI will be done.
Phase 2: Prospective data validation Patients referred for the Lexiscan stress MPI will be followed prospectively after obtaining an informed consent. All comers after June 1 2012 will be included. Prediction of coronary artery disease will be performed by applying the previously derived pathological RV criteria on the prospective stress MPIs. 2D-Echocardiogram will be performed for all the patients who do not have an Echocardiogram performed for clinical indication within 1 month of their index Lexiscan stress MPI. We will also include 100 patients referred for the exercise stress MPI who will serve as controls.
All patients will be prospectively followed up for a total of 12 months for the following prognostic end points:
- Hard cardiac events (cardiac death or MI);
- Total (all-cause) mortality;
- Cardiovascular hospitalization rate. Cardiac death (CD) will be defined as death attributable to any cardiac cause (eg, lethal arrhythmia, myocardial infarction [MI], or pump failure) as confirmed by review of death certificate and medical records.
- Keywords
- right ventricle, radiotracer uptake, Myocardial Perfusion Imaging, balanced ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lexiscan-Echo echo subjects | No Intervention: Observational study | |
| Lexiscan-Echo control subjects | No intervention: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hard cardiac events (cardiac death or MI)
Patient follow-up evaluated for hard cardiac events (cardiac death or MI)in the year post index test determined by telephone interviews or review of medical records
Measured: within 1 year after the index test
Secondary outcomes (2)
Total (all-cause) mortality
Total (all-cause) mortality in the year post index test determined by telephone interviews or review of medical records
Measured: within 1 year after the index test
Cardiovascular hospitalization rate
Cardiovascular hospitalization rate in the year post index test determined by telephone interviews or review of medical records
Measured: within 1 year after the index test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increased Right Ventricular Radiotracer UptakeStudies 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
- Case-control
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aiden Abidov
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor-investigator, Aiden Abidov, University of Arizona
- Investigators
- Aiden Abidov, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697995
- Sponsor's protocol ID
- REGA-11J08
- Acronym
- RVuptakeLexi
- Status last verified
- Nov 2015
- First submitted
- 6 Aug 2012
- 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
- Diagnostic and Prognostic Value of the Stress Induced Right Ventricular Uptake on Lexiscan Stress MPI in Patients With Known or Suspected Coronary Artery Disease (CAD).
- ClinicalTrials.gov ID
- NCT01697995
- Acronym / sponsor ID
- RVuptakeLexi / REGA-11J08
- Keywords
- right ventricle, radiotracer uptake, Myocardial Perfusion Imaging, balanced ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Aiden AbidovUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Jan 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Oct 2012 (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.
The objectives of this study are to determine the:
- Diagnostic value of stress induced RV changes on Lexiscan stress MPI as compared to Exercise stress MPI in predicting a significant CAD.
- Prognostic value of stress induced RV changes on Lexiscan stress MPI in predicting adverse short-term and long-term clinical outcomes after the index test.
Detailed description
Phase 1: Retrospective data collection/analysis All Lexiscan and exercise MPI images on patients performed for clinical indications in calendar year 2010 who had subsequent coronary angiogram within 3 months after index MPI will be retrieved for review by two experts. We will identify different types of RV uptake and RV overload during stress as well as presence or absence of these changes on resting images. Analysis will include increased RV uptake, enlargement, hypertrophy, thinning of RV and flattening of the interventricular septum. Diagnostic performance (sensitivity, specificity and diagnostic accuracy) of the identified pathological RV phenotypes in identifying severe and extensive disease will be evaluated by comparison with contrary angiograms. Comparison of the set of parameters identifying pathological RV changes, identifying normal and abnormal values of these novel ancillary markers, as well as assessing their diagnostic accuracy in patients with suspected and known CAD during vasodilator stress versus exercise stress MPI will be done.
Phase 2: Prospective data validation Patients referred for the Lexiscan stress MPI will be followed prospectively after obtaining an informed consent. All comers after June 1 2012 will be included. Prediction of coronary artery disease will be performed by applying the previously derived pathological RV criteria on the prospective stress MPIs. 2D-Echocardiogram will be performed for all the patients who do not have an Echocardiogram performed for clinical indication within 1 month of their index Lexiscan stress MPI. We will also include 100 patients referred for the exercise stress MPI who will serve as controls.
All patients will be prospectively followed up for a total of 12 months for the following prognostic end points:
- Hard cardiac events (cardiac death or MI);
- Total (all-cause) mortality;
- Cardiovascular hospitalization rate. Cardiac death (CD) will be defined as death attributable to any cardiac cause (eg, lethal arrhythmia, myocardial infarction [MI], or pump failure) as confirmed by review of death certificate and medical records.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lexiscan-Echo echo subjects | – | –No Intervention: Observational study |
| Lexiscan-Echo control subjects | – | –No intervention: observational study |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Retrospective population (approximately 300 charts to be reviewed) * Patients with MPI and 2D Echocardiogram within one month of the stress testing in calendar year 2010 at University Medical Center, Tucson AZ. * 18 years or older 2. Prospective population (approximately 350 subjects to be recruited) * Patients scheduled for MPI at University Medical Center, Tucson AZ, and invited to participate in this study. * 18 years to 89 years old
Key inclusion criteria (14 listed)
- Retrospective population (approximately 300 charts to be reviewed)
- Prospective population (approximately 350 subjects to be recruited)
- patients with nondiagnostic or technically defective MPI
- incomplete clinical data
- severe valvular heart disease
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hard cardiac events (cardiac death or MI)
Time frame: within 1 year after the index test
Patient follow-up evaluated for hard cardiac events (cardiac death or MI)in the year post index test determined by telephone interviews or review of medical records
2 secondary outcomes
Total (all-cause) mortality
Time frame: within 1 year after the index test
Cardiovascular hospitalization rate
Time frame: within 1 year after the index test
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.
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 principal investigator
University of Arizona
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 Increased Right Ventricular Radiotracer Uptake, 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 14 inclusion and 0 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?
Hard cardiac events (cardiac death or MI) (time frame: within 1 year after the index test). 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.