Clinical trial NCT03693157: The Safety and Efficacy of FFR Protocol in NTUH System
Official title: The Safety and Efficacy of Current FFR Measurement in NTUH Health Care System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bradyarrhythmia
Dyspnea
Acute Respiratory Failure
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects who had intermediate lesion over the coronary artery and eligible for FFR examination

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.

Eligibility criteria: Inclusion Criteria:

* Eligible for FFR examination

Exclusion Criteria:

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

Primary outcomes:
measure: Adenosine related adverse event
timeFrame: 24 hours
measure: Major adverse cardiac event (MACE)
timeFrame: 2 year
Secondary outcomes:
measure: The relationship between left ventricular diastolic pressure and maximum dosage of IC adenosine
timeFrame: 1 hour
Other outcomes:
measure: The relationship between pro-BNP,hs-CRP and maximum dosage of IC adenosine
timeFrame: 1 day
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu branch
Study officials:
affiliation: National Taiwan University Hospital, Hsinchu Branch.
name: Chien-Boon Jong, MD
role: PRINCIPAL_INVESTIGATOR
References: