Prognosis of Very Low Dose SPECT

Completed

• Conditions: Chest Pain

• Registration Number: NCT01387152
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-06-30
• Study First Posted: 2011-07-04
• Study Start: 2011-11
• Primary Completion: 2012-11
• Study Completion: 2015-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients free of composite endpoint	3 months after MPS and hospital discharge (an expected average of 12 hours after MPS)	Composite endpoint consists of: * death; * non-fatal myocardial infarction; * unstable angina; * repeat emergency department visit for chest pain evaluation,or repeat anatomical or functional cardiac imaging

Secondary Outcome Measures

Name	Time	Method
Duration of stress test	Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Image quality on a 5 point scale	Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)	Imagine quality is assessed by 2 readers and is scored on a 5-point scale: excellent, very good, good, fair, poor.
Average effective dose received by patients for whom stress-only MPS is performed.	Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Percentage of patients for whom rest imaging is needed.	12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Average effective dose of radiation received by all patients.	Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Duration of hospitalization	Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)

Trial Locations

Locations (1)

New York Presbyterian Hospital- Columbia University Medical Center; 🇺🇸 New York, New York, United States