Coronary Artery Disease
Conditions
Keywords
Coronary artery disease, Fractional flow reserve, NTG-Pd/Pa, Saline-Pd/Pa
Brief summary
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.
Detailed description
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 1. To evaluate the numerical difference between NTG-Pd/Pa and saline-Pd/Pa. 2. To test the repeatability of saline-Pd/Pa. 3. To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR assessment. 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.
Interventions
DIAGNOSTIC_TESTNTG-Pd/Pa measurement
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.
DIAGNOSTIC_TESTSaline-Pd/Pa measurement
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.
Sponsors
Miaoli General Hospital, Ministry of Health and Welfare, Taiwan
Taichung Veterans General Hospital
National Taiwan University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with coronary artery with 50-90% stenosis. * In participants who suffered from ST elevation myocardial infarction within 5 days, only the non-culprit vessel was eligible for coronary functional testing.
Exclusion criteria
* Systolic blood pressure is less than 90 mmHg for more than 5 minutes during examination. * Resting heart rate is less than 50 beats per minute. * Heart failure remains decompensated at the time of examination, such as inability to lie flat or cardiogenic shock. * Acute onset of asthma or chronic obstructive pulmonary disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute difference between NTG-Pd/Pa and Saline-Pd/Pa value | 3 minutes | The absolute difference was calculated as the Saline-Pd/Pa value minus the NTG-Pd/Pa value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of NTG-Pd/Pa and Saline-Pd/Pa | 4 minutes | To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR≤0.80. |
| Repeatability of Saline-Pd/Pa | 2 minutes | Saline-Pd/Pa will be measured at one-minute intervals, and the absolute differences between consecutive measurements will be analyzed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Target vessel failure | 3 years | The target vessel failure included target vessel myocardial infarction, target vessel restenosis or revascularization. |
Countries
Taiwan
Outcome results
None listed