Prognosis of Very Low Dose SPECT

Chest Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387152
• Other study ID #: AAAI0383
• Secondary ID: 10-MYO-003
• Status: Completed
• Phase: N/A
• First received: June 29, 2011
• Last updated: February 2, 2015
• Start date: November 2011
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

See brief summary above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2015
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chest Pain

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital- Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Percentage of patients for whom rest imaging is needed.		12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Duration of stress test		Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)	No
Secondary	Duration of hospitalization		Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)	No