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

Sponsor

National Taiwan University Hospital Hsin-Chu Branch (Other)

Overall Status

Recruiting

CT.gov ID

NCT04700397

Collaborator

(none)

100

Enrollment

Location

37.9

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypotension Symptomatic Ischemic Heart Disease	Diagnostic Test: Nitroglycerine

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 2, 2021

Anticipated Primary Completion Date :

Feb 29, 2024

Anticipated Study Completion Date :

Feb 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
Repeatability group 1 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.	Diagnostic Test: Nitroglycerine We aim to test the repeatability of NTG-Pd/Pa with different dosages of nitroglycerine injection.
Repeatability group 2 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.	Diagnostic Test: Nitroglycerine We aim to test the repeatability of NTG-Pd/Pa with different dosages of nitroglycerine injection.
Repeatability group 3 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.	Diagnostic Test: Nitroglycerine We aim to test the repeatability of NTG-Pd/Pa with different dosages of nitroglycerine injection.
pressure-recommended doses of NTG 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.	Diagnostic Test: Nitroglycerine We aim to test the repeatability of NTG-Pd/Pa with different dosages of nitroglycerine injection.

Outcome Measures

Primary Outcome Measures

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

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 Outcome Measures

Nitroglycerine related adverse events [1 hour]
Including symptomatic hypotension or severe headache

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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