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Prognosis of Very Low Dose SPECT

This study is currently recruiting participants.
Verified August 2012 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Andrew J. Einstein, MD, PhD, Columbia University
ClinicalTrials.gov Identifier:
NCT01387152
First received: June 29, 2011
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition
Chest Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognosis of Very Low Dose Stress First Myocardial Perfusion SPECT in Patients With Chest Pain Using an Alcyone Camera

Resource links provided by NLM:

MedlinePlus related topics: Chest Pain
U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Percentage of patients free of composite endpoint [ Time Frame: 3 months after MPS and hospital discharge (an expected average of 12 hours after MPS) ] [ Designated as safety issue: No ]

    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:
  • Percentage of patients for whom rest imaging is needed. [ Time Frame: 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS) ] [ Designated as safety issue: No ]
  • Image quality on a 5 point scale [ Time Frame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS) ] [ Designated as safety issue: No ]
    Imagine quality is assessed by 2 readers and is scored on a 5-point scale: excellent, very good, good, fair, poor.

  • Average effective dose of radiation received by all patients. [ Time Frame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS) ] [ Designated as safety issue: No ]
  • Average effective dose received by patients for whom stress-only MPS is performed. [ Time Frame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS) ] [ Designated as safety issue: No ]
  • Duration of stress test [ Time Frame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS) ] [ Designated as safety issue: No ]
  • Duration of hospitalization [ Time Frame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS) ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

See brief summary above.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387152

Contacts
Contact: Andrew J Einstein, MD, PhD 212-305-6812 andrew.einstein@columbia.edu

Locations
United States, New York
New York Presbyterian Hospital- Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Andrew J Einstein, MD, PhD     212-305-6812     andrew.einstein@columbia.edu    
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Andrew J Einstein, MD, PhD NYPH- Columbia University Medical Center
  More Information

No publications provided

Responsible Party: Andrew J. Einstein, MD, PhD, Assistant Professor of Medicine, Radiology, Columbia University
ClinicalTrials.gov Identifier: NCT01387152     History of Changes
Other Study ID Numbers: AAAI0383, 10-MYO-003
Study First Received: June 29, 2011
Last Updated: August 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
chest pain
myocardial perfusion scintigraphy
nuclear stress testing
low radiation dose

Additional relevant MeSH terms:
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013