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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03693157
Enrollment
250
Registered
2018-10-02
Start date
2018-11-07
Completion date
2022-12-31
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, Bradyarrhythmia, Dyspnea

Brief 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.

Interventions

None listed

Sponsors

National Taiwan University Hospital Hsin-Chu Branch
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Eligible for FFR examination

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Adenosine related adverse event24 hoursIncluding 1. Bradyarrhythmia including sinus pause and transient AV block 2. Acute respiratory failure define by respiratory distress which need mechanical ventilator support
Major adverse cardiac event (MACE)2 yearMACE including target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death

Secondary

MeasureTime frameDescription
The relationship between left ventricular diastolic pressure and maximum dosage of IC adenosine1 hourDetermine the correlation of left ventricular diastolic pressure and peak dosage of IC adenosine with FFR protocol in NTUH system

Other

MeasureTime frameDescription
The relationship between pro-BNP,hs-CRP and maximum dosage of IC adenosine1 dayDetermine the correlation of pro-BNP,,hs-CRP and peak dosage of IC adenosine with FFR protocol in NTUH system

Countries

Taiwan

Contacts

Primary ContactChien-Boon Jong, MD
jgboon0407@gmail.com+88635322140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026