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Verification of Metabonomic Diagnosis of Myocardial Ischemia

Status Approved

First Submitted Date

2018/05/18
Registered Date

2018/06/23
Last Updated Date

2018/06/08

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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	KCT0002952
Unique Protocol ID	KNUH201606016
Public/Brief Title	Metabolomic Diagnosis of Myocardial Ischemia
Scientific Title	Verification of Metabonomic Diagnosis of Myocardial Ischemia
Acronym
MFDS Regulated Study	No
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 2016-06-016-001
Approval Date	2016-07-18
Institutional Review Board Name	Kyungpook national university hospital Institutional Review Board
Institutional Review Board Address	135, Dongdeok-ro, Jung-gu, Daegu,Korea
Institutional Review Board Telephone	053-200-5430
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	DONGHEON YANG
Title	PI
Telephone	+82-53-200-6587
Affiliation	Kyungpook National University Hospital
Address	130 Dongdeok-ro, Jung-gu, Daegu 41944, Korea
Contact Person for Public Queries
Name	JIHYEONG CHOI
Title	CRC
Telephone	+82-53-200-6721
Affiliation	Kyungpook National University Hospital
Address	130 Dongdeok-ro, Jung-gu, Daegu 41944, Korea
Contact Person for Updating Information
Name	JIHYEONG CHOI
Title	CRC
Telephone	+82-53-200-6721
Affiliation	Kyungpook National University Hospital
Address	130 Dongdeok-ro, Jung-gu, Daegu 41944, 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
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2016-11-09 Actual
Target Number of Participant	50
Primary Completion Date	2017-11-01 , Actual
Study Completion Date	2017-11-01 , Actual
Name of Study	Kyungpook National University Hospital
Recruitment Status	Completed
Date of First Enrollment	2016-11-09 ,

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	Kyungpook National University Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyungpook National University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Background: Because of population ageing, the prevalence of coronary artery disease (CAD) is increasing. For the management of CAD, the clinical benefit of ischemia-guided percutaneous intervention (PCI) has been proven by many clinical trials, and many guideline-publishing authorities recommend ischemia-guided PCI as the standard treatment of CAD. However, functional tests used for diagnosis of CAD is not frequently performed in daily practices, due to the inherent limitation of them. Hypothesis: Analysis of serum metabolomic profiles can identify patients who have myocardial ischemia Objective: Development of a novel metabolomic tool to diagnoses myocardial ischemia Methods: - Patients complaining of chest pain and scheduled to undergo coronary angiography (CAG) will be enrolled (n = 50) - Blood sampling will be performed for these patients before, 10 min, 1hr, and 4 hr after treadmill ECG test (TMT) - Patients who show a positive TMT result and have significant coronary stenosis on CAG will be classified as the experimental group - Patients who show a negative TMT result and have not significant coronary stenosis on CAG will be classifed as the control group - Though an analysis of serum metabolomic profiles, a statistical model will be developed to diagnose myocardial ischemia

Study Summary Information

Lay Summary

Background: 
Because of population ageing, the prevalence of coronary artery disease (CAD) is increasing. For the management of CAD, the clinical benefit of ischemia-guided percutaneous intervention (PCI) has been proven by many clinical trials, and many guideline-publishing authorities recommend ischemia-guided PCI as the standard treatment of CAD. However, functional tests used for diagnosis of CAD is not frequently performed in daily practices, due to the inherent limitation of them. 
Hypothesis: Analysis of serum metabolomic profiles can identify patients who have myocardial ischemia
Objective: Development of a novel metabolomic tool to diagnoses myocardial ischemia
Methods:
- Patients complaining of chest pain and scheduled to undergo coronary angiography (CAG) will be enrolled (n = 50)
- Blood sampling will be performed for these patients before, 10 min, 1hr, and 4 hr after treadmill ECG test (TMT)
- Patients who show a positive TMT result and have significant coronary stenosis on CAG will be classified as the experimental group
- Patients who show a negative TMT result and have not significant coronary stenosis on CAG will be classifed as the control group
- Though an analysis of serum metabolomic profiles, a statistical model will be developed to diagnose myocardial ischemia

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	Cohort
Time Perspective	Prospective
Target Number of Participant	50
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label myocardial ischemia group
Cohort/ Group 1	Cohort/Group Description - Patients who show a positive TMT result and have significant coronary stenosis on CAG - Blood sampling will be performed for these patients before, 10 min, 1hr, and 4 hr after treadmill ECG test (TMT) - Meta-bolomic profiling will be performed via the Blood samples
Cohort/ Group 2	Cohort/Group Label normal coronary angiography group
Cohort/ Group 2	Cohort/Group Description - Patients who show a negative TMT result and have not significant coronary stenosis on CAG - Blood sampling will be performed for these patients before, 10 min, 1hr, and 4 hr after treadmill ECG test (TMT) - Meta-bolomic profiling will be performed via the Blood samples
Biospecimen Collection & Archiving	: DNA Collect & Archive: Sample without DNA
Biospecimen Description	plasma

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Adults who have chest pain, and are >= 18 years old
Sampling Method	Convenience sampling: Complaining of chest pain and scheduled to undergo coronary angiography, patients who is admitted to Kyungpook national university hospital will be enrolled
Condition(s)/Problem(s)	* (R00-R99)Symptoms, signs and abnormal clinical and laboratory findings, NEC (R07.4)Chest pain, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~No Limit
	Description chest pain patients who are suspected of having coronary artery disease and scheduled to receive coronary angiography
Exclusion Criteria	- Musculoskeletal disease precluding treadmill test - Acute coronary syndrome (unstable angian, and myocardial infarction) - Moderate or severe valvular heart disease - Left ventricular ejection fraction <= 50% - Clinically significant chronic obstructive pulmonary disease - Other systemic disease limiting physical performce - Baseline ECG abnormality - Fail to achieve the target heart rate (>= 85% of Max. HR) in the abscence of symptom or sign of myocardial ischemia
Healthy Volunteers

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Serum metabolomic profile after treadmill test
Timepoint	10 min after treadmill test
Secondary Outcome(s) 1
Outcome	Serum metabolomic profile before treadmill test
Timepoint	before treadmill test
Secondary Outcome(s) 2
Outcome	Serum metabolomic profile after treadmill test
Timepoint	1 hr after treadmill test
Secondary Outcome(s) 3
Outcome	Serum metabolomic profile after treadmill test
Timepoint	4hr after treadmill test

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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