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:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT01842035
Eligibility Criteria:
Inclusion criteria:
* Age 19-80 years
* Female subjects must be (a) at least one year post-menopause or surgically sterile or (b) be non-pregnant and (c) non-lactating.
* Subject must be able and willing to provide written informed consent
* Subject must be referred for a clinically indicated ICD and fall into one of the following groups:
* subjects with left ventricular ejection fraction less than 35% due to prior myocardial infarction who are at least 40 days post-myocardial infarction and are in NYHA functional Class II or III.
* subjects with non-ischemic dilated cardiomyopathy who have a left ventricular ejection fraction less than or equal to 35% and who are in NYHA functional Class II or III.
* Subjects with left ventricular dysfunction due to prior myocardial infarction who are at least 40 days post-myocardial infarction, have a left ventricular ejection fraction less than 30%, and are in NYHA functional Class I.
Exclusion Criteria:
* Female subject who is pregnant or lactating
* Subject with active severe asthma or chronic obstructive pulmonary disease which, in the Investigator's opinion, places the subject at risk for severe bronchoconstriction
* Treatment with dipyridamole, theophylline, aminophylline or pentoxifylline within 24 hours of receiving regadenoson
* Treatment with any investigational drug within 30 days or 5 half lives - whichever is longer prior to study entry
* Subject with any prior allergic response to aminophylline or other contraindication to receiving intravenous regadenoson
* Subjects with second or third degree atrioventricular block or dependent on pacemaker
* Subject with uncontrolled severe hypertension (systolic \> 200 mmHg or diastolic \>120 mmHg) or pretreatment hypotension (systolic BP \<90 mmHg)
* Subject with hemodynamically significant aortic stenosis or outflow tract obstruction
* Subject with decompensated heart failure (NYHA functional class IV)
* Subject with acute myocardial infarction, new onset of ischemia, percutaneous coronary intervention, or coronary artery bypass grafting within 30 days of receiving regadenoson
* Subject is on dialysis for end stage renal disease or has an estimated glomerular filtration rate \< 15 mL/min
* Subjects with cardiac transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT01842035
Study Brief:
Protocol Section:
NCT01842035