Prognosis of Very Low Dose SPECT

Columbia University

Status: Completed

Conditions: Chest Pain

Study type: Observational

Funder types: Other

Identifiers

NCT01387152

AAAI0383

10-MYO-003 (Other Grant/Funding Number)

Details and patient eligibility

About

Nuclear stress testing evaluates whether the heart receives enough blood, by injection of a nuclear isotope during a stress on the heart that permits taking pictures of the heart muscle. A low-radiation-dose protocol for nuclear stress testing involves injecting less of the nuclear isotope than standard protocols, by utilizing a new, more efficient camera (called an Alcyone camera) which could decrease radiation dose to patients while still providing excellent clinical information. Subjects will undergo imaging under the Alcyone camera after undergoing stress testing with exercise or a standard medication simulating exercise, and then at rest if needed. Subjects will have follow-up to measure events occurring after the test, such as death, heart attack, unstable angina, repeat emergency department visit for chest pain evaluation, or repeat imaging needed to evaluation for coronary artery disease. Radiation doses and quality of the images from the imaging with the new protocol will be recorded to compare to those used in standard nuclear imaging protocols. The primary study hypothesis is that greater than 90% of patients who have a normal very low dose stress first myocardial perfusion scintigraphy (MPS) will be free at 3 months after study of death, nonfatal myocardial infarction, unstable angina, and repeat emergency department visit for chest pain evaluation or repeat anatomical or functional cardiac imaging.

Full description

See brief summary above.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting with chest pain but normal or nondiagnostic electrocardiograms and at least 3 negative troponin levels taken 4 or more hours apart.
• Age greater than 18 years.
• Written informed consent is obtained by a study investigator.

Exclusion criteria

• Previous Myocardial perfusion scintigraphy (MPS) with evidence of scar
• Previous MPS with evidence of ischemia and no subsequent revascularization
• Known dilated left ventricle
• Known cardiomyopathy
• High pre-test probability of a perfusion defect on MPS
• Body mass index greater than 35
• Prisoner status

Trial design

100 participants in 1 patient group

Very low dose stress test protocol

Description:

Patients admitted to New York Presbyterian Hospital (NYPH)-Columbia University Medical Center with chest pain but normal or nondiagnostic electrocardiograms and at least 3 negative troponins taken 4 or more hours apart, and undergo exercise or pharmacologic stress testing using a very low dose (\<6 mCi) of Tc99m tetrofosmin or sestamibi with imaging performed using acquisitions with an Alcyone camera.