Stress Induced Right Ventricular Uptake on Lexiscan Stress MPI (RVuptakeLexi)
|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: NCT01697995|
Recruitment Status : Unknown
Verified November 2015 by Aiden Abidov, University of Arizona.
Recruitment status was: Enrolling by invitation
First Posted : October 2, 2012
Last Update Posted : November 4, 2015
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.
|Condition or disease|
|Increased Right Ventricular Radiotracer Uptake|
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 Type :||Observational|
|Estimated Enrollment :||650 participants|
|Observational Model:||Case Control|
|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).|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||December 2016|
Lexiscan-Echo echo subjects
No Intervention: Observational study
Lexiscan-Echo control subjects
No intervention: observational study
- 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
- Total (all-cause) mortality [ Time Frame: within 1 year after the index test ]Total (all-cause) mortality in the year post index test determined by telephone interviews or review of medical records
- Cardiovascular hospitalization rate [ Time Frame: within 1 year after the index test ]Cardiovascular hospitalization rate in the year post index test determined by telephone interviews or review of medical records
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): NCT01697995
|United States, Arizona|
|University of Arizona Medical Center|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Aiden Abidov, MD||University of Arizona|