The Safety and Efficacy of FFR Protocol in NTUH System

Dyspnea Clinical Trial

Official title:

The Safety and Efficacy of Current FFR Measurement in NTUH Health Care System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03693157
• Other study ID #: 107-052-E
• Status: Recruiting
• Start date: November 7, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: February 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

FFR-guided PCI has been performed in National Taiwan University Hospital(NTUH) for many years. Nevertheless, the method of FFR measurement in NTUH is different from that in literature. In this study, the investigator would like to evaluate the effectiveness and safety of NTUH experience in FFR prospectively. First, the investigator will record any intracoronary (IC) injected adenosine-related complications, such as bradyarrhythmia or chest discomfort. Second, the investigator will follow up on the clinical outcome of the participants for 2 years, record if any target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death. Finally, left ventricular diastolic pressure, serum pro-brain natriuretic peptide (pro-BNP), and high sensitivity C- reactive protein (hsCRP) will be checked and determined their relationships with the maximum dosage of IC adenosine.

Description:

FFR has been introduced for the determination of physiological ischemia in the myocardium for many years. Nowadays, FFR-guided PCI is highly recommended for the assessment of physiologic ischemia in intermediate coronary lesions. FFR-guided PCI has been performed in National Taiwan University Hospital(NTUH) for many years. Nevertheless, the method of FFR measurement in NTUH is different from that in literature. In this study, the investigator would like to evaluate the effectiveness and safety of NTUH experience in FFR prospectively. First, the investigator will record any intracoronary (IC) injected adenosine-related complications, such as bradyarrhythmia or chest discomfort. Second, the investigator will follow up on the clinical outcome of the participants for 2 years, record if any target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death. Finally, left ventricular diastolic pressure, serum pro-brain natriuretic peptide (pro-BNP), and high sensitivity C- reactive protein (hsCRP) will be checked and determined their relationships with the maximum dosage of IC adenosine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Eligible for FFR examination

Exclusion Criteria:

• Hypersensitivity to adenosine
• Severe valvular aortic stenosis
• Resting heart rate less than 50 beats per minute

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Bradyarrhythmia
• Bradycardia
• Dyspnea
• Respiratory Insufficiency

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	The relationship between pro-BNP,hs-CRP and maximum dosage of IC adenosine	Determine the correlation of pro-BNP,,hs-CRP and peak dosage of IC adenosine with FFR protocol in NTUH system	1 day
Primary	Adenosine related adverse event	Including; Bradyarrhythmia including sinus pause and transient AV block; Acute respiratory failure define by respiratory distress which need mechanical ventilator support	24 hours
Primary	Major adverse cardiac event (MACE)	MACE including target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death	2 year
Secondary	The relationship between left ventricular diastolic pressure and maximum dosage of IC adenosine	Determine the correlation of left ventricular diastolic pressure and peak dosage of IC adenosine with FFR protocol in NTUH system	1 hour