Myocardial Stress Perfusion Computed Tomography in the Evaluation of Patients With Acute Chest Pain Using a Novel 3rd Generation Dual-source CT System

NCT ID: NCT02308475

Last Updated: 2018-07-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-07-06

Brief Summary

To assess the ability of a novel 3rd generation dual-source CT system to demonstrate myocardial perfusion in a cohort of patients presenting to the Chest Pain Center with acute chest pain.

Detailed Description

The investigators will assess the latest generation of CT scanner for heart disease detection. On this new machine the investigators will analyse the ability of the machine to show the delivery of blood to the heart muscle. Results will be compared with the results from the gold standard test for myocardial perfusion imaging, which is an imaging test that shows the blood supply to the heart muscle. Further analyses will record the amount of radiation, which is how the CT machine acquires images, and compare the amount of radiation necessary to produce images to previous CT systems. With this new CT system there should be reductions in the amount of radiation dose compared to previous systems.

Conditions

Chest Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Myocardial Stress CT Perfusion

Dynamic volume CT myocardial perfusion using the experimental scanner (Force, Siemens), applying the "dynamic shuttle" mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium.

Group Type: EXPERIMENTAL

Somatom Force CT Scanner

Intervention Type: DEVICE

Dynamic CT perfusion of the heart

Interventions

Somatom Force CT Scanner

Dynamic CT perfusion of the heart

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject must present with symptoms of acute but atypical or recurrent chest pain.
• Subject must have been referred for cardiac CT angiography OR subject must have undergone clinically indicated SPECT with positive or equivocal findings OR subject must have undergone clinically indicated SPECT with prior cardiac CT angiography that showed moderate or severe stenosis.
• Subject must be 18-85 years of age.
• Subject must provide written informed consent prior to any study-related procedures being conducted.
• Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria

• Subject is a pregnant or nursing female.
• Subject has severe asthma or COPD requiring frequent inhaler use.
• Subject has prior diagnosis of obstructive CAD that has not been revascularized.
• Subject with implanted rhythm devices (pacemaker, defibrillator).
• Subject has significant arrhythmia.
• Subject has high grade heart block.
• Subject has resting heart rate < 45 bpm, systolic blood pressure <90 mm Hg, or has consumed caffeine within the last 12 hours.
• Subject has an acute psychiatric disorder.
• Subject is unwilling to comply with the requirements of the protocol.
• Subject has previously entered this study.
• Subject has an allergy against iodinated contrast or pharmaceutical stressors used in this study.
• Subject suffers from claustrophobia.
• Subject has impaired renal function (creatinine > 1.5 mg/dl).
• Subject is in unstable condition.
• ST-elevations, new transient ST changes greater than 0.05mV or T-wave inversions with symptoms.
• Subject cannot safely be administered Lexiscan per prescribing information as as determined by investigator.
• Subject has received interventional (PCI, stenting) or surgical (CABG) treatment that may alter the cardiac condition regarding myocardial perfusion status and/or stenosis degree between cardiac CTA, SPECT, and/or CT stress perfusion studies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

U. Joseph Schoepf, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro31584

Identifier Type: -

Identifier Source: org_study_id