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

Not Applicable

Terminated

• Conditions: Chest Pain
• Interventions: Device: Somatom Force CT Scanner

• Registration Number: NCT02308475
• Lead Sponsor: Medical University of South Carolina

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-11-21
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-04
• Primary Completion: 2015-07-06
• Study Completion: 2015-07-06
• Results First Submitted: 2018-04-30
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-04
• Last Update Submitted: 2018-06-04
• Results First Posted: 2018-07-06
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myocardial Stress CT Perfusion	Somatom Force CT Scanner	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy of Dynamic Perfusion CT	1 Day	The diagnostic accuracy of dynamic perfusion CT of the heart for evaluation of perfusion, viability and function during stress and rest will be compared with SPECT myocardial perfusion imaging using p-values for comparison of reader specific values, calculated by means of the McNemar test.

Secondary Outcome Measures

Name	Time	Method
CTMP/SPECT MPI Disagreement	1 Day	Evaluate the accuracy of CT myocardial perfusion and SPECT using a stress/rest and delayed enhancement MRI examination as gold-standard by means of Kappa analysis
Radiation Dose	1 Day	Assess the radiation dose (in mGy) delivered with the myocardial perfusion CT comparing the results with those obtained at SPECT.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States