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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03693157
Other study ID # 107-052-E
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 7, 2018
Est. completion date December 31, 2022

Study information

Verified date February 2021
Source National Taiwan University Hospital Hsin-Chu Branch
Contact Chien-Boon Jong, MD
Phone +88635322140
Email jgboon0407@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Eligible for FFR examination Exclusion Criteria: - Hypersensitivity to adenosine - Severe valvular aortic stenosis - Resting heart rate less than 50 beats per minute

Study Design


Locations

Country Name City State
Taiwan National Taiwan University Hospital Hsin-Chu branch Hsinchu

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other The relationship between pro-BNP,hs-CRP and maximum dosage of IC adenosine Determine the correlation of pro-BNP,,hs-CRP and peak dosage of IC adenosine with FFR protocol in NTUH system 1 day
Primary Adenosine related adverse event Including
Bradyarrhythmia including sinus pause and transient AV block
Acute respiratory failure define by respiratory distress which need mechanical ventilator support
24 hours
Primary Major adverse cardiac event (MACE) MACE including target lesion failure, target vessel failure, target vessel-related myocardial infarction, and cardiac death 2 year
Secondary The relationship between left ventricular diastolic pressure and maximum dosage of IC adenosine Determine the correlation of left ventricular diastolic pressure and peak dosage of IC adenosine with FFR protocol in NTUH system 1 hour
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