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

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.

Study Overview

• Status: Terminated
• Conditions: Chest Pain
• Intervention / Treatment: Device: Somatom Force CT Scanner

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: Somatom Force CT Scanner; Dynamic CT perfusion of the heart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy of Dynamic Perfusion CT	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.	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CTMP/SPECT MPI Disagreement	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	1 Day
Radiation Dose	Assess the radiation dose (in mGy) delivered with the myocardial perfusion CT comparing the results with those obtained at SPECT.	1 Day

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): July 6, 2015
• Study Completion (ACTUAL): July 6, 2015

Study Registration Dates

• First Submitted: November 21, 2014
• First Submitted That Met QC Criteria: December 3, 2014
• First Posted (ESTIMATE): December 4, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain
• Other Study ID Numbers: Pro31584