Hypotension Symptomatic, Ischemic Heart Disease
Conditions
Keywords
NTG-Pd/Pa, Fractional flow reserve, adenosine
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.
Interventions
DIAGNOSTIC_TESTNitroglycerine
We aim to test the repeatability of NTG-Pd/Pa with different dosages of nitroglycerine injection.
Sponsors
National Taiwan University Hospital Hsin-Chu Branch
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible for FFR examination
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac event | 2 years | MACE including target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death |
| Diagnostic accuracy of NTG-Pd/Pa 1 | 30 minutes | Investigate the diagnostic accuracy of NTG-Pd/Pa, with FFR≤0.8 as ischemic threshold |
| Diagnostic accuracy of NTG-Pd/Pa 2 | 30 minutes | Investigate the diagnostic accuracy of NTG-Pd/Pa, with RFR≤0.89 as ischemic threshold |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nitroglycerine related adverse events | 1 hour | Including symptomatic hypotension or severe headache |
Countries
Taiwan
Contacts
Primary ContactChien-Boon Jong, MD
Outcome results
None listed