Prognosis of Very Low Dose SPECT

NCT01387152 | Completed

• 2 other identifiers: AAAI038310-MYO-003
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain

Keywords

chest pain; myocardial perfusion scintigraphy; nuclear stress testing; low radiation dose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  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)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

New York Presbyterian Hospital- Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew J Einstein, MD, PhD

  NYPH- Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Radiology

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 4, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2015
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

US (1)