Phase 4
Completed N=43
Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET
Source: ClinicalTrials.gov NCT01109992 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Safety and Tolerability of Combined Exercise and Regadenoson Stress — 0; 3; 3; 0 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Combined Exercise and Regadenoson Stress |
0; 3; 3; 0; 0; 0 | — |
| SECONDARY Image Quality: Heart to Liver Ratio of Counts |
1.23; 1.11; 1.25; 1.37 | — |
| SECONDARY Changes in Left Ventricular Function With Dual Exercise and Regadenoson PET |
58; 60; 59; 62 | — |
| SECONDARY Peak Stress Myocardial Blood Flow |
1.82; 2.04; 1.85; 2.34 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT01109992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.