Clinical trial NCT01387152: Prognosis of Very Low Dose SPECT
Official title: Prognosis of Very Low Dose Stress First Myocardial Perfusion SPECT in Patients With Chest Pain Using an Alcyone Camera
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Keywords: chest pain
myocardial perfusion scintigraphy
nuclear stress testing
low radiation dose
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2011-07-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects will be patients who have presented to NYPH- Columbia University Medical Center with chest pain.

Brief summary: 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.

Detailed description: See brief summary above.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients free of composite endpoint
timeFrame: 3 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Secondary outcomes:
measure: Percentage of patients for whom rest imaging is needed.
timeFrame: 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
measure: Image quality on a 5 point scale
timeFrame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
measure: Average effective dose of radiation received by all patients.
timeFrame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
measure: Average effective dose received by patients for whom stress-only MPS is performed.
timeFrame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
measure: Duration of stress test
timeFrame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
measure: Duration of hospitalization
timeFrame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital- Columbia University Medical Center
state: New York
Study officials:
affiliation: NYPH- Columbia University Medical Center
name: Andrew J Einstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: