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Comparative Study on Effect of Pharmacological Stress with Nicorandil and Adenosine to Diagnostic Performance of Myocardial Perfusion SPECT in Ischemic Heart Diseases

Status Approved

  • First Submitted Date

    2018/09/01

  • Registered Date

    2019/01/16

  • Last Updated Date

    2018/10/08

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003432
    Unique Protocol ID KNUH-2017-05-009-004
    Public/Brief Title Nicorandil Stress Myocardial Perfusion SPECT Study compared with Adenosine Stress
    Scientific Title Comparative Study on Effect of Pharmacological Stress with Nicorandil and Adenosine to Diagnostic Performance of Myocardial Perfusion SPECT in Ischemic Heart Diseases
    Acronym NicoStudy
    MFDS Regulated Study Yes
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KNUH-2017-05-009-002
    Approval Date 2017-09-11
    Institutional Review Board Name Kangwon National University Hospital Institutional Review Board
    Institutional Review Board Address 156, Baengnyeong-ro, Chuncheon-si, Gangwon-do
    Institutional Review Board Telephone 033-258-9199
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name In Kook Chun
    Title Asistant Professor
    Telephone +82-33-258-9041
    Affiliation Kangwon National University Hospital
    Address 156 Baengnyeong-ro, Chuncheon-si, Gangwon-do, Republic of Korea
    Contact Person for Public Queries
    Name In Kook Chun
    Title BSc, MD, PhD
    Telephone +82-33-258-9041
    Affiliation Kangwon National University Hospital
    Address 156 Baengnyeong-ro, Chuncheon-si, Gangwon-do, Republic of Korea
    Contact Person for Updating Information
    Name In Kook Chun
    Title BSc, MD, PhD
    Telephone +82-33-258-9041
    Affiliation Kangwon National University Hospital
    Address 156 Baengnyeong-ro, Chuncheon-si, Gangwon-do, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2017-09-25 Actual
    Target Number of Participant 50
    Primary Completion Date 2018-08-28 , Actual
    Study Completion Date 2018-09-03 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Kangwon National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2017-09-25 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Kangwon National University Hospital
    Organization Type Medical Institute
    Project ID KNUH-2017-05-009-004
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Kangwon National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    There is no report on the direct comparative analysis of the diagnostic performance of the existing adenosine-stressed myocardial perfusion SPECT and nicorandil-stressed myocardial perfusion SPECT in ischemic heart disease. In the present study, if it is proved that nicorandil is a useful drug for a substitute for adenosine in myocardial perfusion SPECT, it will be expected that the result will give  a ripple effect on diagnosis, response evaluation, and prognosis prediction of patients with ischemic heart disease.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-control
    Time Perspective Prospective  
    Target Number of Participant 50
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    Nicorandil Group

    Cohort/Group Description

    1) Nicorandil (continuous IV infusion of 0.2mg/kg for 5 min) is used as a phamacological stress agent, which is followed by a radiopharmaceutical, Tc-99m sestamibi for myocardial perfusion SPECT.
    2) Any adverse effect including symptoms and signs during infusion of nicorandil is reviewed during and after myocardial perfusion SPECT.
    3) Quantitative and semi-quantitative parameters are calculated for evaluation of cardiac function.
    Cohort/
    Group 2

    Cohort/Group Label

    Adenosine Group

    Cohort/Group Description

    1) Adenosine (continuous IV infusion at 140 mcg/kg/min for 6 min) is used as a phamacological stress agent in myocardial perfusion SPECT.
    2) A radiopharmaceutical, Tc-99m sestamibi is intravenously administered at 3 min after initiation of adenosine infusion.
    3) Any adverse effect including symptoms and signs during infusion of nicorandil is reviewed during and after myocardial perfusion SPECT.
    4) Quantitative and semi-quantitative parameters are calculated for evaluation of cardiac function.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    male and female patients aged over 40 visiting kangwon national university hospital
    Sampling Method
    screening of outpatients visiting department of cardiology
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I25.9)Chronic ischaemic heart disease, unspecified 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    40Year~No Limit

    Description

    ① suspected ischemic heart disease patient who will undergo coronary angiography 
     a) previously healthy patient: no previous medical history with diagnosis of or treatment for coronary heart disease
     b) known ischemic heart disease patient: patient with new symptoms including chest pain, dyspnea, etc. within recent 1 month
    ② both male and female patients aged over 40
    Exclusion Criteria
    ① Severe renal failure, hepatic failure, brain function disorders, hypotension, cardiogenic shoke, or other physical or psycological problems that make the patient difficult to participate in the current study 
    ② contraindications to adenosine or nicorandil as below:
     a) adenosine: hypersensitivity reaction, 2nd/3rd degree AV block, sick sinus syndrome, chronic obstructive pulmonary disease, long QT syndrome, severe hypotension, uncompensated heart failure, refractory unstable angina, dipyridamol use
     b) nicorandil: severe hepatic/renal dysfunction, severe brain dysfunction, severe hypotension or cardiogenic shock, Eisenmenger syndrome or primary hypertension, right ventricular infarction, dehydration symptoms, neurocirculatory asthenia, 
    narrow angle glaucoma, history of hypersensitiveness to nicorandil or nitric acid/nitrite ester agents, use of phosphodiesterase-5 (PDE-5) or guanylate cyclase
    ③ pregnancy or breast feeding
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome clinical-equivalence
    Primary Outcome(s) 1
    Outcome
    adverse effect: flushing, dyspnea, chest pain, gastrointestinal discomfort, headache, dizziness, hypotension, palpitation, weakness, nausea/vomiting, abdominal pain, back pain, toothache, nasal congestion, throat-neck discomfort, etc.
    Timepoint
    during and after administration of adenosine or nicorandil
    Primary Outcome(s) 2
    Outcome
    diagnostic performance for ischemic heart disease: sensitivity and specificity
    Timepoint
    after final diagnosis
    Secondary Outcome(s) 1
    Outcome
    Quantitative and semi-quantitative parameters from myocardial perfusion SPECT: left ventricular ejection fraction, myocardial blood flow udner rest (MBF-Re), myocardial blood flow udner stress (MBF-St), respectively), myocardial blood flow increasing rate (MBF-IR), sum of rest scores (SRS), sum of stress scores (SSS), sum of difference scores (SDS), etc.
    Timepoint
    after final diagnosis
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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