Ignite Creation Date:
2024-05-06 @ 12:56 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01697995
Status:
UNKNOWN
Last Update Posted:
2015-11-04
First Post:
2012-08-06
Brief Title:
Stress Induced Right Ventricular Uptake on Lexiscan Stress MPI
Sponsor:
Aiden Abidov
Organization:
University of Arizona
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RVuptakeLexi
Brief 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 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
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
Detailed Description:
Phase 1 Retrospective data collectionanalysis 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None