Clinical trial NCT04700397: A Validation Study of Nitroglycerin Induced Acute Drop of Pd/Pa (NTG-Pd/Pa) in Clinical Practice
Official title: A Validation Study of Nitroglycerin Induced Acute Drop of Pd/Pa (NTG-Pd/Pa) in Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypotension Symptomatic
Ischemic Heart Disease
Keywords: NTG-Pd/Pa, Fractional flow reserve, adenosine
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had intermediate lesion over the coronary artery and eligible for FFR examination

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.

Eligibility criteria: 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

Primary outcomes:
measure: The repeatability and dose response of NTG-Pd/Pa
timeFrame: 10 minutes
Secondary outcomes:
measure: Major adverse cardiac event
timeFrame: 2 years
measure: Diagnostic accuracy of NTG-Pd/Pa 1
timeFrame: 30 minutes
measure: Diagnostic accuracy of NTG-Pd/Pa 2
timeFrame: 30 minutes
Other outcomes:
measure: Nitroglycerine related adverse events
timeFrame: 1 hour
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu branch
Study officials:
affiliation: National Taiwan University Hospital, Hsinchu Branch.
name: Chien-Boon Jong, MD
role: PRINCIPAL_INVESTIGATOR
References: