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A Study on Improved Dynamic Myocardial Perfusion With Less Effective Radiation Dose in CT (SIMPLE CT)

Primary Purpose

Myocardial Ischemia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Myocardial CT perfusion
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Ischemia focused on measuring Myocardial ischemia, Coronary artery disease, Myocardial CT perfusion, Modified scan protocol, Diagnostic performance, Radiation dose

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men and women patients, with age ranging 30-80.
  2. Known or suspected coronary artery disease who are supposed to undergo invasive coronary angiography
  3. Patients who are willing to sign the informed consent form

Exclusion Criteria:

  1. Contraindication of CT

    • Known allergy to iodinated contrast media or history of contrast-induced nephropathy
    • Decreased renal function: elevated serum creatinine (>1.5 mg/dl)
    • Severe arrhythmia: atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block)
    • Severe thyroid disease
    • Homocystinuria
    • History of asthma
    • Hypersensitivity to adenosine
    • Severe obstructive lung disease
    • Intake of caffeine or xanthine-containing compounds within the last 48 hours

  2. Contraindication of MRI

    • Claustrophobia
    • Metallic hazards
    • Pacemaker implant
    • eGFR (estimated glomerular filtration rate) <30 ml/min
    • Clipping for aneurysm (stainless steel clips), neurostimulator, cochlear implant.
  3. Unstable or uncooperative patients
  4. Limited life expectancy due to cancer or end-stage renal or liver disease
  5. Evidence of severe symptomatic heart failure (NYHA Class III or IV)
  6. Acute myocardial infarction, hypertrophic cardiomyopathy, dilated cardiomyopathy, coronary artery bypass surgery, or other cardiac surgery
  7. Women with positive pregnancy tests

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Myocardial CT perfusion (21-second)

Myocardial CT perfusion (30-second)

Arm Description

A total of 60 symptomatic patients will be randomized to dynamic CT perfusion protocol with 21-second scan duration.

A total of 60 symptomatic patients will be randomized to dynamic CT perfusion protocol with 30-second scan duration.

Outcomes

Primary Outcome Measures

AUC (area under the curve) of CT perfusion for detection of perfusion defects : 30-second scanning protocol versus 21-second scanning protocol
There were no significant differences in the diagnostic performances between two CTP protocols with different scan duration.

Secondary Outcome Measures

Effective radiation dose for each component of the CT examination is calculated as the product of the dose-length product multiplied by a conversion coefficient of 0.014 (mSv/[mGycm]).
CTP with shorter scan duration resulted in a 23% reduction of radiation dose compared with 30-second scan protocol

Full Information

First Posted
March 31, 2014
Last Updated
December 5, 2017
Sponsor
Samsung Medical Center
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02161081
Brief Title
A Study on Improved Dynamic Myocardial Perfusion With Less Effective Radiation Dose in CT (SIMPLE CT)
Official Title
Adenosine-induced Stress Myocardial Perfusion Imaging With Dual-source 128-slice CT: a Study on the Comparison of Diagnostic Performance of Dynamic Scanning Protocols
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Among the current myocardial CT perfusion techniques, dynamic CT perfusion technique is most advantageous in obtaining information on myocardial blood flow and volume. However, dynamic CT perfusion technique involves higher radiation dose than static CT techniques. Patients have to take a breath hold during 30 seconds with current dynamic CT perfusion protocol. If patients cannot hold their breath, anterior or inferior myocardium might be excluded due to limited scan coverage of a 128-slice dual-source CT scanner. Reduction of scanning duration of dynamic CT perfusion may not only reduce radiation exposure, but also make patients more comfortable. Therefore, the investigators intended to propose a modified scan protocol with shorter scan duration and compare diagnostic accuracy of a modified scan protocol with the current scan protocol.
Detailed Description
The aim of this study is to compare the diagnostic performance of adenosine-stress dynamic myocardial CT perfusion using a reduced dynamic scan duration with perfusion protocol of 30-second scan duration for the detection of myocardial perfusion defect and significant coronary artery stenosis. This trial is a single center, prospective, randomized trial designed to compare diagnostic performances and radiation doses between two protocols with 30-second or 21-second dynamic scan durations. A total of 120 symptomatic patients will be randomized to dynamic CT perfusion protocols with 30-second or 21-second scan duration. They will also undergo 1.5-T MRI and invasive coronary angiography as reference standards for the assessment of myocardial perfusion and coronary artery stenosis. The primary end point of the study is to compare diagnostic performances between two CT protocols of dynamic CT perfusion. The secondary endpoint of this study is to compare radiation doses and image qualities of two scan protocols.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
Myocardial ischemia, Coronary artery disease, Myocardial CT perfusion, Modified scan protocol, Diagnostic performance, Radiation dose

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myocardial CT perfusion (21-second)
Arm Type
Experimental
Arm Description
A total of 60 symptomatic patients will be randomized to dynamic CT perfusion protocol with 21-second scan duration.
Arm Title
Myocardial CT perfusion (30-second)
Arm Type
Active Comparator
Arm Description
A total of 60 symptomatic patients will be randomized to dynamic CT perfusion protocol with 30-second scan duration.
Intervention Type
Procedure
Intervention Name(s)
Myocardial CT perfusion
Intervention Description
Adenosine-stress dynamic myocardial CT perfusion using 128-slice dual-source CT
Primary Outcome Measure Information:
Title
AUC (area under the curve) of CT perfusion for detection of perfusion defects : 30-second scanning protocol versus 21-second scanning protocol
Description
There were no significant differences in the diagnostic performances between two CTP protocols with different scan duration.
Time Frame
When all randomized patients underwent CT scanning (A total of 120 symptomatic patients will be randomized to dynamic CT perfusion protocols with 30-second or 21-second scan duration.)
Secondary Outcome Measure Information:
Title
Effective radiation dose for each component of the CT examination is calculated as the product of the dose-length product multiplied by a conversion coefficient of 0.014 (mSv/[mGycm]).
Description
CTP with shorter scan duration resulted in a 23% reduction of radiation dose compared with 30-second scan protocol
Time Frame
up to 1 week after each patient underwent CT scanning

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women patients, with age ranging 30-80. Known or suspected coronary artery disease who are supposed to undergo invasive coronary angiography Patients who are willing to sign the informed consent form Exclusion Criteria: Contraindication of CT Known allergy to iodinated contrast media or history of contrast-induced nephropathy Decreased renal function: elevated serum creatinine (>1.5 mg/dl) Severe arrhythmia: atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block) Severe thyroid disease Homocystinuria History of asthma Hypersensitivity to adenosine Severe obstructive lung disease Intake of caffeine or xanthine-containing compounds within the last 48 hours Contraindication of MRI Claustrophobia Metallic hazards Pacemaker implant eGFR (estimated glomerular filtration rate) <30 ml/min Clipping for aneurysm (stainless steel clips), neurostimulator, cochlear implant. Unstable or uncooperative patients Limited life expectancy due to cancer or end-stage renal or liver disease Evidence of severe symptomatic heart failure (NYHA Class III or IV) Acute myocardial infarction, hypertrophic cardiomyopathy, dilated cardiomyopathy, coronary artery bypass surgery, or other cardiac surgery Women with positive pregnancy tests
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeon Hyeon Choe, M.D.,Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

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A Study on Improved Dynamic Myocardial Perfusion With Less Effective Radiation Dose in CT (SIMPLE CT)

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