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
CRIS Registration Number |
KCT0003432 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Kangwon National University Hospital |
Organization Type | Medical Institute |
Project ID | KNUH-2017-05-009-004 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Kangwon National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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. |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | male and female patients aged over 40 visiting kangwon national university hospital |
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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 |
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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)
Type of Primary Outcome | clinical-equivalence | |
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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 |
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Primary Outcome(s) 2 | ||
Outcome | diagnostic performance for ischemic heart disease: sensitivity and specificity |
|
Timepoint | after final diagnosis |
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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. |
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Timepoint | after final diagnosis |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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