The Safety and Efficacy of FFR Protocol in NTUH System

NCT ID: NCT03693157

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-07
• Study Completion Date: 2022-12-31

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.

Conditions

Bradyarrhythmia; Dyspnea; Acute Respiratory Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chien-Boon Jong, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital, Hsinchu Branch.

Locations

National Taiwan University Hospital Hsin-Chu branch

Hsinchu, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chien-Boon Jong, MD

Role: CONTACT

jgboon0407@gmail.com

+88635322140

Facility Contacts

Chien-Boon Jong, MD

Role: primary

jgboon0407@gmail.com

035322140

Other Identifiers

107-052-E

Identifier Type: -

Identifier Source: org_study_id