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

Ischemic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04700397
• Other study ID #: 109-081-E
• Status: Recruiting
• Start date: January 2, 2021
• Est. completion date: February 29, 2024

Study information

• Verified date: January 2021
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: Chien-Boon Jong, MD
• Phone: +88635322140
• Email: jgboon0407[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Hypotension
• Hypotension Symptomatic
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Nitroglycerine
We aim to test the repeatability of NTG-Pd/Pa with different dosages of nitroglycerine injection.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Hsin-Chu branch	Hsinchu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nitroglycerine related adverse events	Including symptomatic hypotension or severe headache	1 hour
Primary	The repeatability and dose response of NTG-Pd/Pa	Comparing the difference of NTG-Pd/Pa value after various dosage of nitroglycerine injection in the same coronary lesion	10 minutes
Secondary	Major adverse cardiac event	MACE including target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death	2 years
Secondary	Diagnostic accuracy of NTG-Pd/Pa 1	Investigate the diagnostic accuracy of NTG-Pd/Pa, with FFR=0.8 as ischemic threshold	30 minutes
Secondary	Diagnostic accuracy of NTG-Pd/Pa 2	Investigate the diagnostic accuracy of NTG-Pd/Pa, with RFR=0.89 as ischemic threshold	30 minutes