NCT03693157

The Safety and Efficacy of FFR Protocol in NTUH System

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: National Taiwan University Hospital Hsin-Chu Branch · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bradyarrhythmia
• Dyspnea
• Acute Respiratory Failure

Timeline

• Start date: 2018-11-07
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2018-10-02
• Last updated: 2021-03-01

Locations

1 site across 1 country: Taiwan