None listed
Conditions
Interventions
FOR SUBJECTS WHO WERE REFERRED FOR PHARMACOLOGICAL STRESS TESTING, THE SUBJECTS SHOULD HAVE A REASONABLE POTENTIAL TO UNDERGO AN EXERCISE STRESS IN THE OPINION OF THE INVESTIGATOR. SUBJECTS WILL BE SC
85 % MAXIMUM PREDICTED HEART RATE (MPHR) AND ACHIEVE 5 METS WILL NOT BE RANDOMIZED INTO THE STUDY AND WILL BE CONSIDERED A SCREEN FAILURE, IN ADDITION IF THE SUBJECTS MEET ACC/AHA 2002 PRACTICE GUIDE
Sponsors
Astellas Pharma Global Development, Inc. (APGD),
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. INSTITUCIONAL REVIEW BOARD (IRB)-/INDEPENDENT ETHICS COMMITTEE (IEC)-APPROVED WRITTEN INFORMED CONSENT AND PRIVACY LANGUAGE AS PER NATIONAL REGULATIONS (E.G., HIPAA AUTORIZATION FOR U.S. SITES) MUST BE OBTAINED FROM THE SUBJECT OR LEGALLY AUTHORIZED REPRESENTATIVE PRIOR TO ANY STUDY-RELATED PROCEDURES (INCLUDING WITHDRAWAL OF PROHIBITED MEDICATION, IF APPLICABLE). 2. MALE AND FEMALE SUBJECT ≥ 18 YEARS OF AGE REFERRED FOR AN EXERCISE OR PHARMACOLOGIC STRESS TEST SPECT MPI PROCEDURE FOR THE EVALUATION OF CORONARY ARTERY DISEASE ARE ELIGIBLE FOR STUDY PARTICIPATION. SUBJECTS REFERRED FOR PHARMACOLOGIC STRESS SHOULD HAVE A REASONABLE POTENTIAL OF ATTEMPTING EXERCISE STRESS IN THE OPINION OF THE INVESTIGATOR. SUBJECT MUST HAVE ONE OF THE FOLLOWING: A. PAST ISCHEMIA ON ANY PRIOR IMAGING STRESS TEST WITHOUT INVASIVE INTERVENTION ON THE ARTERY SUBTENDING THIS TERRITORY. B. SUBJECT WITH KNOWN CAD WHO HAVE SYMPTOMS SIMILAR TO PREVIOUS ISCHEMIC SYMPTOMS, OR RECENT ONSET OF SYMPTOMS OR RECENTLY WORSENED SYMPTOMS SUGGESTIVE OF ISCHEMIA. C. DIAMOND FORRESTER ESTIMATED PRETEST PROBABILITY OF CAD OF ≥ 50 % (SEE APPENDIX 9).
Exclusion criteria
Exclusion criteria: 1. SUBJECT IS CONCURRENTLY PARTICIPATING IN ANOTHER DRUG STUDY OR HAS RECEIVED AN INVESTIGATIONAL DRUG WITHIN 30 DAYS PRIOR TO SCREENING. 2. SUBJECT HAS A CLINICALLY SIGNIFICANT ILLNESS, MEDICAL CONDITION, OR LABORATORY ABNORMALITY, ACTIVE OR HISTORIC, WHICH IN THE INVESTIGATOR’S OPINION WOULD PRECLUDE PARTICIPATION IN THE STUDY. 3. DURING THE PERFORMANCE OF EXERCISE, IN THE INVESTIGATOR’S JUDGMENT, THE SUBJECT WILL ACHIEVE ≥ 85 % MPHR AND 5 METS OR IN THE INVESTIGATOR’S JUDGMENT, SIGNIFICANT ISCHEMIA IS PRESENT AND PHARMACOLOGICAL STRESS IS NOT REQUIRED. 4. FEMALE SUBJECT WHO IS PREGNANT OR LACTATING. 5. SUBJECT IS ON DIALYSIS FOR END STAGE RENAL DISEASE OR HAS A HISTORY OF GER 4.7 METS UNLESS CURRENTLY TAKING BETA BLOCKERS OR RATE SLOWING CALCIUM CHANNELBLOCKERS, OR HAS KNOWN CHRONOTROPIC INCOMPETENCE (SEE APPENDIX 10).
Countries
United States
Contacts
Public ContactLUIS MELENDEZ
PPD Peru S.A.C.
Outcome results
None listed