Prognosis of Very Low Dose SPECT

Prognosis of Very Low Dose Stress First Myocardial Perfusion SPECT in Patients With Chest Pain Using an Alcyone Camera

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.

Study Overview

• Status: Completed
• Conditions: Chest Pain

Detailed Description

See brief summary above.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital- Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study subjects will be patients who have presented to NYPH- Columbia University Medical Center with chest pain.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients free of composite endpoint	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	3 months after MPS and hospital discharge (an expected average of 12 hours after MPS)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients for whom rest imaging is needed.		12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Image quality on a 5 point scale	Imagine quality is assessed by 2 readers and is scored on a 5-point scale: excellent, very good, good, fair, poor.	Up to 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)
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)
Duration of stress test		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)

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Andrew J Einstein, MD, PhD, NYPH- Columbia University Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: June 30, 2011
• First Posted (Estimate): July 4, 2011

Study Record Updates

• Last Update Posted (Estimate): February 4, 2015
• Last Update Submitted That Met QC Criteria: February 2, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: chest pain; myocardial perfusion scintigraphy; nuclear stress testing; low radiation dose
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain
• Other Study ID Numbers: AAAI0383; 10-MYO-003 (Other Grant/Funding Number: GE Healthcare)