Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Exercise plus Regadenoson (Lexercise); Regadenoson (Lexiscan)
Intervention description: Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography; Regadenoson Rubidium-82 Positron Emission Tomography
Intervention MeSH terms: Regadenoson
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: coronary artery disease; exercise; regadenoson; positron emission tomography

Summary:

      This is a single-center study of subjects undergoing clinically indicated heart scans for
      evaluation of known or suspected heart disease. We will also include 10 healthy subjects
      without known heart disease. We would like to study stress testing of the heart using
      exercise and a medication called regadenoson. Imaging of the heart will be performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  Clinically indicated N-13 ammonia PET study or ten healthy volunteers

          -  Known coronary artery disease (prior percutaneous coronary intervention, prior
             coronary artery bypass surgery or Q wave MI on ECG) or intermediate to high pretest
             likelihood of CAD

          -  Able to exercise on a treadmill

          -  Able and willing to provide informed consent to participate in the study

        Exclusion Criteria:

          -  Contraindications to exercise stress testing such as, unstable angina, known severe
             left main coronary artery stenosis, severe heart failure, uncontrolled arrhythmias,
             symptomatic hypotension or severe hypertension (systolic blood pressure < 90 or > 200
             mmHg, respectively), or > 1st degree atrioventricular block in the absence of a
             functioning pacemaker.

          -  Subject requires emergent cardiac medical intervention or catheterization after the
             clinical study.

          -  Documented myocardial infarction (MI) ≤ 30 days prior to enrollment.

          -  History of percutaneous coronary intervention (PCI) ≤ 4weeks prior to enrollment.

          -  History of coronary artery bypass graft (CABG) ≤ 8 weeks prior to enrollment.

          -  History of heart transplantation.

          -  Allergy or intolerance to aminophylline or regadenoson

          -  Known severe or oxygen dependent bronchoconstrictive or bronchospastic lung disease
             [e.g., asthma, wheezing, chronic obstructive pulmonary disease (COPD), etc.].

          -  Severe LV dysfunction, with ejection fraction of < 30%

          -  Serious non-cardiac medical illness (e.g., disseminated malignancy, severe
             neurological dysfunction at time of baseline PET study) or a social situation which
             will preclude research study participation

          -  History of Seizures.