Increased Right Ventricular Radiotracer Uptake Clinical Trial
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:
1. Diagnostic value of stress induced RV changes on Lexiscan stress MPI as compared to
Exercise stress MPI in predicting a significant CAD.
2. 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.
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:
1. Hard cardiac events (cardiac death or MI);
2. Total (all-cause) mortality;
3. 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.
;
Observational Model: Case Control