A Validation Study of Nitroglycerin Induced Acute Drop of Pd/Pa (NTG-Pd/Pa) in Clinical Practice
- Conditions
- Hypotension SymptomaticIschemic Heart Disease
- Interventions
- Diagnostic Test: Nitroglycerine
- Registration Number
- NCT04700397
- Lead Sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Brief Summary
Hyperemia with adenosine was an elemental process in FFR examination. Adenosine injection will induce some discomfort, and increase cost expenditure. Nitroglycerine will induce an acute drop of Pd/Pa, and this lowest Pd/Pa was determined as NTG-Pd/Pa. NTG-Pd/Pa has a linear relationship with FFR value and has a good diagnostic accuracy to predict FFR≤0.80 in our recent study. There is only one prospective study report on the relationship between NTG-Pd/Pa and FFR. In this study, we aim to evaluate the safety of NTG-Pd/Pa, the repeatability and dose-response of this novel index. Furthermore, we will investigate the diagnostic accuracy of NTG-Pd/Pa, with FFR≤0.8 and Resting full-cycle ratio≤0.89 as ischemic threshold respectively.
- Detailed Description
Fractional flow reserve (FFR) is defined as the ratio of mean distal pressure (distal to the target lesion, Pd）to mean proximal pressure (aortic pressure, Pa) in the coronary artery(Pd/Pa) while the maximal hyperemic flow is achieved. Nowadays, FFR-guided PCI is highly recommended for the assessment of physiologic ischemia in intermediate coronary lesions. However, hyperemia with adenosine was an elemental process in FFR examination. Adenosine injection will induce some discomfort, and increase cost expenditure. Based on the clinical and physiologic outcome study, a lot of non-hyperemic indexes had been proposed, and adenosine injection could be waived. Whereas, these novel physiologic indexes are limited to the proprietary software of each vendor, curtailing clinical application. Intracoronary nitroglycerin injection was needed before each FFR assessment. Nitroglycerine will induce an acute drop of Pd/Pa, and this lowest Pd/Pa was determined as NTG-Pd/Pa. NTG-Pd/Pa has a linear relationship with FFR value and has a good diagnostic accuracy to predict FFR≤0.80 in our recent study. There is only one prospective study report on the relationship between NTG-Pd/Pa and FFR. In this study, we aim to evaluate the safety of NTG-Pd/Pa, the repeatability and dose-response of this novel index. Furthermore, we will investigate the diagnostic accuracy of NTG-Pd/Pa, with FFR≤0.8 and Resting full-cycle ratio≤0.89 as ischemic threshold respectively.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Eligible for FFR examination
- Hypersensitivity to adenosine or nitroglycerine
- Severe Valvular aortic stenosis
- Resting heart rate less than 50 beats per minutes
- Systolic blood pressure less than 100 mmHg or diastolic blood pressure less than 40 mmHg
- exposure to PDE-5 inhibitors within 48 hours.
- Recent intracranial hemorrhage or brain injury
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description pressure-recommended doses of NTG Nitroglycerine The patient with systolic blood pressure above 100 mmHg, who will receive the nitroglycerine injection with the dose of recommendation, adjusted according to the blood pressure. Repeatability group 1 Nitroglycerine The patient with systolic blood pressure above 120 mmHg, who will receive a repeatability test with 200mcg, then another 100 mcg nitroglycerine injection, with a time interval of 3 minutes apart. Repeatability group 2 Nitroglycerine The patient with systolic blood pressure above 120 mmHg, who will receive a repeatability test with 200mcg, then another 200 mcg nitroglycerine injection, with a time interval of 3 minutes apart. Repeatability group 3 Nitroglycerine The patient with systolic blood pressure above 120 mmHg, who will receive a repeatability test with 200mcg, then another 300 mcg nitroglycerine injection, with a time interval of 3 minutes apart.
- Primary Outcome Measures
Name Time Method The repeatability and dose response of NTG-Pd/Pa 10 minutes Comparing the difference of NTG-Pd/Pa value after various dosage of nitroglycerine injection in the same coronary lesion
- Secondary Outcome Measures
Name Time Method Diagnostic accuracy of NTG-Pd/Pa 2 30 minutes Investigate the diagnostic accuracy of NTG-Pd/Pa, with RFR≤0.89 as ischemic threshold
Diagnostic accuracy of NTG-Pd/Pa 1 30 minutes Investigate the diagnostic accuracy of NTG-Pd/Pa, with FFR≤0.8 as ischemic threshold
Major adverse cardiac event 2 years MACE including target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death
Trial Locations
- Locations (1)
National Taiwan University Hospital Hsin-Chu branch
🇨🇳Hsinchu, Taiwan