Back to resultsMyocardial Stress Perfusion Computed Tomography in the Evaluation of Patients With Acute Chest Pain Using a Novel 3rd Generation Dual-source CT System
Primary Purpose
Chest Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Somatom Force CT Scanner
Sponsored by
About this trial
This is an interventional diagnostic trial for Chest Pain
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.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Myocardial Stress CT Perfusion
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Radiation Dose
Assess the radiation dose (in mGy) delivered with the myocardial perfusion CT comparing the results with those obtained at SPECT.
Full Information
NCT ID
NCT02308475
First Posted
November 21, 2014
Last Updated
June 4, 2018
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT02308475
Brief Title
Myocardial Stress Perfusion Computed Tomography in the Evaluation of Patients With Acute Chest Pain Using a Novel 3rd Generation Dual-source CT System
Official Title
Myocardial Stress Perfusion Computed Tomography in the Evaluation of Patients With Acute Chest Pain Using a Novel 3rd Generation Dual-source CT System
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
New study with a similar endpoint/protocol was developed (see NCT03103061).
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 6, 2015 (Actual)
Study Completion Date
July 6, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Myocardial Stress CT Perfusion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Somatom Force CT Scanner
Intervention Description
Dynamic CT perfusion of the heart
Primary Outcome Measure Information:
Title
Diagnostic Accuracy of Dynamic Perfusion CT
Description
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.
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
CTMP/SPECT MPI Disagreement
Description
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
Time Frame
1 Day
Title
Radiation Dose
Description
Assess the radiation dose (in mGy) delivered with the myocardial perfusion CT comparing the results with those obtained at SPECT.
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
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Myocardial Stress Perfusion Computed Tomography in the Evaluation of Patients With Acute Chest Pain Using a Novel 3rd Generation Dual-source CT System
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