The Safety and Efficacy of FFR Protocol in NTUH System
The Safety and Efficacy of Current FFR Measurement in NTUH Health Care System
1 other identifier
observational
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2018
CompletedFirst Posted
Study publicly available on registry
October 2, 2018
CompletedStudy Start
First participant enrolled
November 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 1, 2021
February 1, 2021
4.2 years
September 27, 2018
February 24, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Adenosine related adverse event
Including 1. Bradyarrhythmia including sinus pause and transient AV block 2. Acute respiratory failure define by respiratory distress which need mechanical ventilator support
24 hours
Major adverse cardiac event (MACE)
MACE including target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death
2 year
Secondary Outcomes (1)
The relationship between left ventricular diastolic pressure and maximum dosage of IC adenosine
1 hour
Other Outcomes (1)
The relationship between pro-BNP,hs-CRP and maximum dosage of IC adenosine
1 day
Eligibility Criteria
All subjects 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
- Severe valvular aortic stenosis
- Resting heart rate less than 50 beats per minute
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital Hsin-Chu branch
Hsinchu, 300, Taiwan
Biospecimen
blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chien-Boon Jong, MD
National Taiwan University Hospital, Hsinchu Branch.
Central Study Contacts
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
September 27, 2018
First Posted
October 2, 2018
Study Start
November 7, 2018
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
March 1, 2021
Record last verified: 2021-02