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

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ClinicalTrials.gov Identifier: NCT02161081
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Samsung Medical Center

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.


Condition or disease Intervention/treatment Phase
Myocardial Ischemia Procedure: Myocardial CT perfusion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
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
Actual Study Start Date : January 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Experimental: Myocardial CT perfusion (21-second)
A total of 60 symptomatic patients will be randomized to dynamic CT perfusion protocol with 21-second scan duration.
Procedure: Myocardial CT perfusion
Adenosine-stress dynamic myocardial CT perfusion using 128-slice dual-source CT

Active Comparator: Myocardial CT perfusion (30-second)
A total of 60 symptomatic patients will be randomized to dynamic CT perfusion protocol with 30-second scan duration.
Procedure: Myocardial CT perfusion
Adenosine-stress dynamic myocardial CT perfusion using 128-slice dual-source CT




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


Secondary Outcome Measures :
  1. 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]). [ Time Frame: up to 1 week after each patient underwent CT scanning ]
    CTP with shorter scan duration resulted in a 23% reduction of radiation dose compared with 30-second scan protocol



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161081


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Bayer
Investigators
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Principal Investigator: Yeon Hyeon Choe, M.D.,Ph.D. Samsung Medical Center
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02161081    
Other Study ID Numbers: SMC2011-05-032-023
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: March 2014
Keywords provided by Samsung Medical Center:
Myocardial ischemia
Coronary artery disease
Myocardial CT perfusion
Modified scan protocol
Diagnostic performance
Radiation dose
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases