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| Name | Class |
|---|---|
| Miaoli General Hospital, Ministry of Health and Welfare, Taiwan | UNKNOWN |
| Taichung Veterans General Hospital | OTHER |
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The goal of this observational study is to compare the value of NTG-Pd/Pa and saline-Pd/Pa in participants with intermediate stenosis of the coronary artery. The main questions it aims to answer are:
The numerical difference between NTG-Pd/Pa and saline-Pd/Pa To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR assessment?
Participants will undergo NTG-Pd/Pa, Saline-Pd/Pa, and FFR successively in the target vessel.
Fractional Flow Reserve (FFR) is the gold standard for determining the functional ischemia of coronary arteries with intermediate lesions. Both intracoronary nitroglycerine (NTG) administration and saline administration induce an acute drop in trans-lesional coronary pressure. Both pressure ratios correlate well with FFR values and can reliably predict positive results in FFR assessments. The aims of this study were
Participants will be enrolled prospectively from National Taiwan University Hospital Hsinchu Hospital, Miaoli General Hospital, and Taichung Veterans General Hospital. The coronary artery with intermediate stenosis will undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments sequentially. Saline-Pd/Pa will be tested repeatedly during the assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Participants will undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments sequentially. Saline-Pd/Pa will be tested repeatedly during the assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTG-Pd/Pa measurement | Diagnostic Test | The coronary artery with intermediate stenosis will sequentially undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments. Intracoronary NTG dosage will follow the protocol based on blood pressure. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute difference between NTG-Pd/Pa and Saline-Pd/Pa value | The absolute difference was calculated as the Saline-Pd/Pa value minus the NTG-Pd/Pa value. | 3 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of NTG-Pd/Pa and Saline-Pd/Pa | To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR≤0.80. | 4 minutes |
| Repeatability of Saline-Pd/Pa |
| Measure | Description | Time Frame |
|---|---|---|
| Target vessel failure | The target vessel failure included target vessel myocardial infarction, target vessel restenosis or revascularization. | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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Participants referred for coronary angiography with intermediate lesions will be invited to join the registry. Enrollment sites include medical facilities in northern and central Taiwan.
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| Name | Affiliation | Role |
|---|---|---|
| Chien Boon Jong, MD | National Taiwan University Hospital, Hsin-Chu Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Hsin-Chu Hospital | Hsinchu | Select | 30047 | Taiwan | ||
| Miaoli General Hospital, Ministry of Health and Welfare |
Data cannot be shared publicly because of ethical restrictions. The restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are from the National Taiwan University Hospital Ethics Committee (contact via ntuhrec@ntuh.gov.tw) for researchers who meet the criteria for access to confidential data.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Serum
| Saline-Pd/Pa measurement | Diagnostic Test | The coronary artery with intermediate stenosis will sequentially undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments. Ten millilitres of intracoronary saline will be given over five seconds. |
|
Saline-Pd/Pa will be measured at one-minute intervals, and the absolute differences between consecutive measurements will be analyzed.
| 2 minutes |
| Miaoli |
| 36054 |
| Taiwan |
| Taichung Veterans General Hospital | Taichung | 407219 | Taiwan |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |