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 @ 10:39 PM
Ignite Modification Date:
2025-12-24 @ 10:39 PM
NCT ID:
NCT03265535
Eligibility Criteria:
Healthy Volunteers:
Inclusion Criteria:
* Subjects must be ≥30 and ≤75 years of age;
* Subjects must provide informed consent prior to study procedures;
Exclusion Criteria:
* History of CAD, including:
* Prior abnormal myocardial perfusion study
* History of MI
* History of angina
* Coronary artery obstruction \>50% on CTA and/or angiography
* Left ventricular ejection fraction \<50%
* Any relative or absolute contraindication to adenosine stress, including:
* 2nd or 3rd degree heart block
* Bradycardia (HR\<50 bpm)
* Recent acute coronary syndrome (ACS)
* Unstable angina
* Severe heart failure (left ventricular ejection fraction \<15%)
* Ventricular arrhythmia
* Severe asthma and/or chronic obstructive pulmonary disease (COPD)
* Baseline hypotension defined as systolic blood pressure \< 90 mmHg
* Caffeine intake within 24 hours prior to imaging
* Current use of theophylline, dipyridamole, or carbamazepine
* Allergy or intolerance to adenosine
* Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
Subjects with CAD:
Inclusion criteria
* Subjects must be ≥30 and ≤75 years of age;
* Subjects must provide informed consent prior to study procedures;
* Abnormal myocardial perfusion study within the past 12 months
Exclusion criteria
* Revascularization (percutaneous coronary intervention and/or coronary artery bypass) following last myocardial perfusion study
* Acute coronary syndrome within 30 days
* Left ventricular ejection fraction \<50%
* Any relative or absolute contraindication to adenosine stress, including:
* 2nd or 3rd degree heart block
* Bradycardia (HR\<50 bpm)
* Recent acute coronary syndrome (ACS)
* Unstable angina
* Severe heart failure (left ventricular ejection fraction \<15%)
* Ventricular arrhythmia
* Severe asthma and/or chronic obstructive pulmonary disease (COPD)
* Baseline hypotension defined as systolic blood pressure \< 90 mmHg
* Caffeine intake within 24 hours prior to imaging
* Current use of theophylline, dipyridamole, or carbamazepine
* Allergy or intolerance to adenosine
* Any clinically significant acute or unstable physical or psychological disease, judged by the investigators, to be incompatible with the study;
* Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
* Female participants only: Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
* Inability to provide written informed consent;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT03265535
Study Brief:
Protocol Section:
NCT03265535