Prognosis of Very Low Dose SPECT

NCT ID: NCT01387152

Last Updated: 2015-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-01-31

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.

Conditions

Chest Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Very low dose stress test protocol

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Andrew J. Einstein, MD, PhD

Associate Professor of Medicine, Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew J Einstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NYPH- Columbia University Medical Center

Locations

New York Presbyterian Hospital- Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

10-MYO-003

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AAAI0383

Identifier Type: -

Identifier Source: org_study_id