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OpenTrials
Completed

NCT Number: NCT01387152

Prognosis of Very Low Dose SPECT

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

New York Presbyterian Hospital- Columbia University Medical Center

New York, 10032, United States

About this study

See brief summary above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of patients free of composite endpoint

    Time frame: 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 outcomes

  1. 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)

  2. 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)

    Imagine quality is assessed by 2 readers and is scored on a 5-point scale: excellent, very good, good, fair, poor.

  3. 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)

  4. 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)

  5. Duration of stress test

    Time frame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)

  6. Duration of hospitalization

    Time frame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2015
First posted
Jul 4, 2011
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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