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

NCT ID: NCT04700397

Last Updated: 2021-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-02
• Study Completion Date: 2024-02-29

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.

Conditions

Hypotension Symptomatic; Ischemic Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Nitroglycerine

Intervention Type: DIAGNOSTIC_TEST

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.

Nitroglycerine

Intervention Type: DIAGNOSTIC_TEST

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.

Nitroglycerine

Intervention Type: DIAGNOSTIC_TEST

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.

Nitroglycerine

Intervention Type: DIAGNOSTIC_TEST

We aim to test the repeatability of NTG-Pd/Pa with different dosages of nitroglycerine injection.

Interventions

Nitroglycerine

We aim to test the repeatability of NTG-Pd/Pa with different dosages of nitroglycerine injection.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chien-Boon Jong, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital, Hsinchu Branch.

Locations

National Taiwan University Hospital Hsin-Chu branch

Hsinchu, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chien-Boon Jong, MD

Role: CONTACT

jgboon0407@gmail.com

+88635322140

Facility Contacts

Chien-Boon Jong, MD

Role: primary

jgboon0407@gmail.com

035322140

Other Identifiers

109-081-E

Identifier Type: -

Identifier Source: org_study_id