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

NCT04700397 | Unknown

• 1 other identifier: 109-081-E
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension Symptomatic; Ischemic Heart Disease

Keywords

NTG-Pd/Pa, Fractional flow reserve, adenosine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Major adverse cardiac event

  2 years

• Diagnostic accuracy of NTG-Pd/Pa 1

  30 minutes

• Diagnostic accuracy of NTG-Pd/Pa 2

  30 minutes

Other Outcomes (1)

• Nitroglycerine related adverse events

  1 hour

Study Arms (4)

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

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

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

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

Interventions

Nitroglycerine DIAGNOSTIC_TEST

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

Repeatability group 1; Repeatability group 2; Repeatability group 3; pressure-recommended doses of NTG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who had intermediate lesion over the coronary artery and eligible for FFR examination

You may qualify if:

• Eligible for FFR examination

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead

Study Sites (1)

National Taiwan University Hospital Hsin-Chu branch

Hsinchu, 300, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling will perform during the FFR exam

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Chien-Boon Jong, MD

  National Taiwan University Hospital, Hsinchu Branch.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Boon Jong, MD

CONTACT

+88635322140; jgboon0407@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 7, 2021
• Study Start: January 2, 2021
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)