Anti-gravity Treadmill Exercise in Stress Myocardial Perfusion Imaging
Completed · Not applicable
Conditions studied: Coronary Artery Disease
In brief
This study will test the hypothesis that the anti-gravity treadmill can be safely used in stress nuclear myocardial perfusion imaging in patients unable to perform conventional treadmill exercise. This will be foundational evidence on which to consider a larger clinical trial to show that the anti-gravity treadmill improves diagnostic specificity across all cardiovascular stress testing modalities including treadmill-alone, exercise stress echocardiogram, exercise SPECT as well as having implications for cardiac PET and MRI in the future.
Key facts
- Study ID
- NCT02628002
- Run by
- University of Cincinnati
- People needed
- 49
- Starts
- 2015-12-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2017-05-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients >18 years of age who are able to ambulate.
- Women will either have a negative pregnancy test, be post-menopausal or have prior surgical infertility
- Nuclear stress SPECT imaging test ordered as exercise SPECT or regadenoson SPECT.
- If ordered for exercise SPECT, self-admission of inability to exercise on conventional treadmill. This typically includes subjects unable to exercise due to obesity, musculoskeletal disease, peripheral vascular disease, weakness or debilitation.
- Patients that initially start conventional treadmill exercise protocol and have to stop due to exercise-limiting symptoms including musculoskeletal pain and fatigue.
- Hemodynamically stable patients as defined by mean blood pressure (BP) >75 mm Hg and heart rate (HR) 60-120 beats per minute.
You may not qualify if…
- Hemodynamically unstable patients as defined by resting mean BP <75 and HR <60 or >120.
- Patients with acute coronary syndrome as defined by troponin elevation (>0.05) within the past 72 hours.
- Patients at high clinical risk related to severe aortic stenosis, known exercise-induced ventricular tachycardia or fibrillation, or advanced (second-degree type II or third-degree) heart block.
- Patients with left bundle branch block or paced cardiac rhythm (in whom exercise is associated with non-ischemic perfusion abnormalities).
- Patients unable to provide consent or unable to cooperate.
- Inability to physically enter onto the anti-gravity treadmill unit.
- Pregnant women.
- Patients with a contraindication to receive regadenoson (sinus node dysfunction, high-degree heart block, active wheezing/reactive airway disease).
- At risk patient populations (prisoners or severely mentally handicapped).
Where it is running
- University of Cincinnati Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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