Stress Induced Right Ventricular Uptake on Lexiscan Stress MPI (RVuptakeLexi)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Aiden Abidov, University of Arizona
ClinicalTrials.gov Identifier:
NCT01697995
First received: August 6, 2012
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.

Condition
Increased Right Ventricular Radiotracer Uptake

Study Type: Observational
Study Design: 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).

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Hard cardiac events (cardiac death or MI) [ Time Frame: within 1 year after the index test ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Total (all-cause) mortality [ Time Frame: within 1 year after the index test ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Cardiovascular hospitalization rate in the year post index test determined by telephone interviews or review of medical records


Estimated Enrollment: 650
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lexiscan-Echo echo subjects
No Intervention: Observational study
Lexiscan-Echo control subjects
No intervention: observational study

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:

  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.
  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  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.
    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697995

Locations
United States, Arizona
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
Aiden Abidov
Astellas Pharma Inc
Investigators
Principal Investigator: Aiden Abidov, MD University of Arizona Sarver Heart Center
  More Information

No publications provided

Responsible Party: Aiden Abidov, Associate Professor of Medicine and Radiology, University of Arizona
ClinicalTrials.gov Identifier: NCT01697995     History of Changes
Other Study ID Numbers: REGA-11J08
Study First Received: August 6, 2012
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
right ventricle
radiotracer uptake
Myocardial Perfusion Imaging
balanced ischemia

Additional relevant MeSH terms:
Regadenoson
Adenosine A2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents
Purinergic Agonists
Purinergic P1 Receptor Agonists

ClinicalTrials.gov processed this record on October 20, 2014