Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT02628002
Eligibility Criteria:
Inclusion Criteria:
1. Patients \>18 years of age who are able to ambulate.
2. Women will either have a negative pregnancy test, be post-menopausal or have prior surgical infertility
3. Nuclear stress SPECT imaging test ordered as exercise SPECT or regadenoson SPECT.
4. 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.
5. Patients that initially start conventional treadmill exercise protocol and have to stop due to exercise-limiting symptoms including musculoskeletal pain and fatigue.
6. Hemodynamically stable patients as defined by mean blood pressure (BP) \>75 mm Hg and heart rate (HR) 60-120 beats per minute.
Exclusion Criteria:
1. Hemodynamically unstable patients as defined by resting mean BP \<75 and HR \<60 or \>120.
2. Patients with acute coronary syndrome as defined by troponin elevation (\>0.05) within the past 72 hours.
3. 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.
4. Patients with left bundle branch block or paced cardiac rhythm (in whom exercise is associated with non-ischemic perfusion abnormalities).
5. Patients unable to provide consent or unable to cooperate.
6. Inability to physically enter onto the anti-gravity treadmill unit.
7. Pregnant women.
8. Patients with a contraindication to receive regadenoson (sinus node dysfunction, high-degree heart block, active wheezing/reactive airway disease).
9. At risk patient populations (prisoners or severely mentally handicapped).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02628002
Study Brief:
Protocol Section:
NCT02628002