A Validation Study of Nitroglycerin Induced Acute Drop of Pd/Pa (NTG-Pd/Pa) in Clinical Practice

National Taiwan University Hospital Hsin-Chu Branch

Status: Unknown

Conditions: Ischemic Heart Disease; Hypotension Symptomatic

Treatments: Diagnostic Test: Nitroglycerine

Study type: Observational

Funder types: Other

Identifiers

NCT04700397

109-081-E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 4 patient groups

Repeatability group 1

Description:

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.

Treatment:

Diagnostic Test: Nitroglycerine

Repeatability group 2

Description:

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.

Treatment:

Diagnostic Test: Nitroglycerine

Repeatability group 3

Description:

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.

Treatment:

Diagnostic Test: Nitroglycerine

pressure-recommended doses of NTG

Description:

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.

Treatment:

Diagnostic Test: Nitroglycerine