The Safety and Efficacy of FFR Protocol in NTUH System
| Tracking Information | |||
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| First Submitted Date ICMJE | September 27, 2018 | ||
| First Posted Date ICMJE | October 2, 2018 | ||
| Last Update Posted Date | October 2, 2018 | ||
| Actual Study Start Date ICMJE | October 3, 2018 | ||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Adenosine related adverse event[ Time Frame: 24 hours ] Including Bradyarrhythmia including sinus pause and transient AV block Acute respiratory failure define by respiratory distress which need mechanical ventilator support Major adverse cardiac event (MACE)[ Time Frame: 2 year ] MACE including target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | The Safety and Efficacy of FFR Protocol in NTUH System |
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| Official Title ICMJE | The Safety and Efficacy of Current FFR Measurement in NTUH Health Care System |
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| Brief Summary | FFR has been introduced for determination of physiological ischemia in myocardium for many years. Nowadays, FFR-guided PCI is highly recommended for 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) 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. |
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| Detailed Description | |||
| Study Type ICMJE | Observational [Patient Registry] | ||
| Study Phase | |||
| Study Design ICMJE | Allocation: Intervention Model: Intervention Model Description: Masking: Observational [Patient Registry] Masking Description: Primary Purpose: |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
250 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | December 31, 2022 | ||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Eligible for FFR examination Exclusion Criteria: - Hypersensitivity to adenosine - Severe valvular aortic stenosis - Resting heart rate less than 50 beats per minute | ||
| Sex/Gender |
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| Ages | 20 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
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| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | ， | ||
| Study Sponsor ICMJE | National Taiwan University Hospital Hsin-Chu Branch | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | |||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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