Phase
Condition
Coronary Artery Disease
Atherosclerosis
Heart Disease
Treatment
13N-ammonia
Ga-68 Galmydar
Clinical Study ID
Ages 18-99 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female, 18-99 years of age and any race;
Have had a prior clinical SPECT or PET MPI positive for ischemia in two myocardialsegments and referred for invasive coronary angiography (ICA) or have had a priorclinical SPECT or PET MPI negative for ischemia or healthy adult normal volunteerswho are asymptomatic, without history of cardiovascular disease or significantcardiovascular risk factors;
Exclusion
Exclusion Criteria:
Inability to receive and sign informed consent;
Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)within 6-months prior to clinical SPECT or PET or in the intervening days betweenclinical SPECT or PET and research PET examination;
Participants who have received chemotherapeutic agents within 6 months ofenrollment;
Heart failure (left ventricular ejection fraction ≤ 20%);
Known non-ischemic cardiomyopathy;
Inability to undergo pharmacologic stress testing with regadenoson (Lexiscan).Contraindications include:
Symptomatic bradycardia or second to third degree atrioventricular (AV) block;
Pre-existing obstructive lung disease with active wheezing, i.e., COPD, asthmawith active wheezing that precludes the safe administration of thepharmacological stress agent according to the approved label;
Uncontrolled and severe hypertension (e.g. systolic blood pressure >200 mmHg,diastolic blood pressure >110 mmHg);
Baseline hypotension (e.g. systolic blood pressure < 90 mmHg, diastolic bloodpressure <50 mmHg);
Women who are pregnant or breastfeeding;
Severe claustrophobia;
Weight ≥ 500 lbs (weight limit of PET/CT table);
Administration of any diagnostic or therapeutic radiopharmaceutical, not part ofthis study, within a period either prior to or after equal to 10 half-lives of theradiopharmaceutical;
Any condition that in the opinion of the Principal Investigator or designee couldincrease risk to the participant, limit the participant's ability to tolerate theresearch procedures or interfere with collection of the data such as:
Inability to lie still or unable to tolerate a supine position with arms upover the head for up to a 60-minute PET scan due to chronic back/shoulder painor arthritis as assessed by physical examination and/or medical history;
Current or past history of major medical illness, i.e. severe kidney or liverproblems;
Patients who suffer an intervening clinical event such as worsening anginapectoris or myocardial infarction or whom undergo a myocardialrevascularization procedure or have myocardial ischemia at rest;
Study Design
Study Description
Connect with a study center
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.