A Phase 3b, Open-Label, Parallel Group, Randomized, Multicenter Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01618669Tipo: INTERVENTIONALInicio: 1 de jun de 2012Fin estimado: 1 de dic de 2014

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to demonstrate that the strength of agreement between single photon emission computed tomography (SPECT) imaging with regadenoson following inadequate exercise stress testing and SPECT imaging with regadenoson alone is not inferior to the strength of agreement between two sequential regadenoson SPECT images without exercise.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Subjects referred for an exercise or pharmacologic stress test SPECT MPI procedure for the evaluation of coronary artery disease (CAD) are eligible for study participation. Subjects referred for pharmacologic stress should have a reasonable potential of attempting exercise stress. 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%
d. History of most recent coronary artery bypass surgery or most recent percutaneous coronary intervention (PCI) \> 10 years (patients who are \> 30 days but less than 10 years post coronary artery bypass graft (CABG) or PCI can be included if they meet criteria a, b, or e)
e. Previously demonstrated 100% occlusion by invasive coronary or computed tomography (CT) angiography without successful intervening revascularization as these foods may alter regadenoson effects

Criterios de exclusión

Subject has a clinically significant illness, medical condition, or laboratory abnormality
Female subject who is pregnant or lactating
Subject is on dialysis for end stage renal disease or has a history of glomerular filtration rate (GFR) \< 15 mL/min (calculated using MDRD \[Modification of Diet in Renal Disease\] formula)
Subject has a history of coronary revascularization by either PCI or CABG within 1 month prior to the rest myocardial perfusion imaging (MPI)
Subject has a pacemaker or an implantable cardioverter defibrillator (ICD)
Subject has a history of acute myocardial infarction (MI) or high risk unstable angina within 30 days prior to the rest MPI or has had cardiac transplantation
Subject has uncontrolled hypertension at any point on Visit 2 prior to exercise testing (i.e., systolic blood pressure (SBP) ≥ 180 or diastolic blood pressure (DBP) ≥ 95 mmHg on two consecutive measurements while at rest).
Subject has severe aortic stenosis or hypertrophic cardiomyopathy with obstruction or has decompensated congestive heart failure
Subject has a history of severe respiratory disease including: asthma, chronic obstructive pulmonary disease (COPD) or other bronchospastic reactive airway disease or who is on 24-hour continuous oxygen

Intervenciones

drug

Regadenoson

Administered as an intravenous (IV) bolus

procedure

Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)

Ubicaciones

Hospital Italiano Garibaldi

Rosario, Santa Fe Province, Argentina

Instituto Oulton

Córdoba, Argentina

Instituto de Cardiologia la Plata

La Plata, Argentina

Hospital Italiano de La Plata

Provincia de Buenos Aires, Argentina

Sanatorio San Geronimo

Santa Fe, Argentina

Patrocinadores

PrincipalAstellas Pharma Global Development, Inc.

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