Low Dose One-Day Tc99m Protocol With a High-Efficiency Cardiac Dedicated Gamma Camera For Detection of Coronary Disease

Spectrum Dynamics

Status: Completed

Conditions: Chest Pain

Treatments: Radiation: low-dose imaging

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01135095

SD-DSPECT002

Details and patient eligibility

About

A prospective single clinical trial to validate the use of a low-dose (~5mSv) Tc-99m protocol with a high-efficiency cardiac dedicated camera (Dynamic Single Photon Emission Computed Tomography; D-SPECT) to detect myocardial perfusion abnormalities during myocardial perfusion imaging.

Full description

as above

Enrollment: 101 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is referred to myocardial perfusion D-SPECT for clinical indications.
2. Written informed consent is obtained by a study investigator.

Exclusion criteria

1. Patient is diagnosed as having uncontrolled congestive cardiac failure or cardiogenic shock.
2. Patient is diagnosed as having uncontrolled hypertension with resting blood pressure > 220 mm Hg systolic or 110 mm Hg diastolic.
3. Patient pregnancy (known or suspected).
4. Lack of written informed consent
5. Prisoner status
6. Minors under the age of 18 as coronary artery disease is generally an adult disease

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

low-dose imaging

Experimental group

Description:

low dose versus standard dose imaging

Treatment:

Radiation: low-dose imaging