RVuptakeLexiDiagnostic and Prognostic Value of the Stress Induced Right Ventricular Uptake on Lexiscan Stress MPI in Patients With Known or Suspected Coronary Artery Disease (CAD).
Data Collection
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: January 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.650 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 89 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: 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 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Arizona Medical Center
Tucson, United StatesOpen University of Arizona Medical Center in Google Maps