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NCT05672706 Clinical Trial

A Study of Pressure Waveform Analysis in Coronary Artery-II

Ischemic Heart Disease Clinical Trial

Official title:
A Study of Pressure Waveform Analysis in Coronary Artery-II

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05672706
Other study ID # 111-129-E
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 4, 2023
Est. completion date December 31, 2027

Study information
Verified date January 2023
Source National Taiwan University Hospital Hsin-Chu Branch
Contact Chien-Boon Jong, MD
Phone 035322140
Email jgboon0407@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational study is to test the feasibility of intracoronary adenosine administration during coronary flow reserve(CFR) and index of microcirculatory resistance(IMR) assessment in a population with angina. The main questions it aims to answer are: - Repeatability of CFR and IMR assessment while hyperemia with intracoronary adenosine was administered. - Evaluate the correlation of the intrinsic signal of coronary waveform versus physiologic ischemia, while defined by fractional flow reserve(FFR) and CFR respectively. - The predictive value of FFR, CFR, and IMR on major adverse cardiovascular outcomes in 3 years Participants will undergo FFR, CFR, and IMR assessments in the catheterization laboratory of the National Taiwan University Hospital Hsin-Chu Branch, then clinical events follow up for 3 years.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 31, 2027
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Participants with angina Exclusion Criteria: - Severe valvular heart disease - History of asthma - Heart rate less than 50 beats per minute - systolic blood pressure less than 90 mmHg

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• CFR and IMR group
Participants will undergo repeat intracoronary adenosine administration during CFR and IMR measurement

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
Primary Repeatability of CFR and IMR value To compare the difference of individual value, while repeat the measurement within 1 minutes 10 minutes
Secondary Major adverse cardiovascular outcomes Including death, myocardial infarction, stroke and heart failure 3 year
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