Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 90
Updated:10/27/2018
Start Date:February 2011
End Date:June 6, 2017

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Integrated Dual Exercise and Lexiscan PET: IDEAL PET

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.

Regadenoson is stress agent approved by the FDA for use with myocardial perfusion imaging
with technetium-99m single photon emission computed tomography (SPECT) in patients that are
unable to exercise adequately. We would like to study Regadenoson in conjunction with
Exercise Rubidium-82 positron emission tomography myocardial perfusion imaging (PET MPI).
Regadenoson is not approved by FDA for use with Rubidium-82 PET MPI. Also, we would like to
study a novel stress protocol of Regadenoson combined with symptom limited exercise stress
(not FDA approved).

The objectives of this study are to assess the tolerability and safety of combined symptom
limited exercise stress test with Lexiscan (Lexercise PET) compared to Lexiscan alone
(Lexiscan PET), to assess image quality of Lexercise compared to Lexiscan PET and to compare
relative and absolute myocardial perfusion imaging with Lexercise compared to Lexiscan PET to
identify CAD.

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.
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Sharmila Dorbala, MBBD, MPH
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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