Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET

Completed · Phase 4

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT01109992

Run by

Brigham and Women's Hospital

People needed

43

Starts

2011-02-01

Expected to finish

2017-06-06

Last updated by the study team

2018-10-25

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Brigham and Womens' Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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